Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
// Substance Batch Analysis
{
"resourceType" : "Bundle",
"id" : "bundle-batch-analysis-pq-ex2-sub",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "2038e4c7-22b8-4c56-2d28-6c077648763f",
"meta" : // specificationProtocol
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"2038e4c7-22b8-4c56-2d28-6c077648763f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: S.4.4 BATCH ANALYSIS</p><p><b>type</b>: Specification Protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (planType#1244577)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></p><p><b>description</b>: Narrative description of analysis</p><blockquote><p><b>action</b></p><p><b>title</b>: Batch Specification for Drug Substance</p><p><b>code</b>: Overall set of actions <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Actions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Definition[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4</code></td></tr><tr><td style=\"display: none\">*</td><td>Test <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td><code>ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4</code></td></tr></table></blockquote></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f",
"title" : "S.4.4 BATCH ANALYSIS",
"type" : // http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
{
"coding" : [
{
"system" : "http://example.org/fhir/code/planType",
"code" : "1244577",
"display" : "Specification Protocol"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
},
"description" : "Narrative description of analysis",
"action" : [
// SubstanceDefinition/substance1
{
"title" : "Batch Specification for Drug Substance",
"code" : // this is then entire thing
{
"text" : "Overall set of actions"
},
"action" : [
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f"
},
// ObservationDefinition/Description
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230"
},
// ObservationDefinition/Identification
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838"
},
// ObservationDefinition/Assay
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
// ObservationDefinition/Impurities
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b"
},
// ObservationDefinition/Mutagenic
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87"
},
// ObservationDefinition/Enantiomeric
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
// ObservationDefinition/Solvents
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4"
},
// ObservationDefinition/Water
{
"code" : {
"text" : "Test"
},
"definitionCanonical" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
}
]
}
]
}
},
// ObservationDefinition/Particles
{
"fullUrl" : "urn:uuid:13033a89-927a-10e0-503e-5f901bdca30f",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "13033a89-927a-10e0-503e-5f901bdca30f",
"text" : // Description
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"13033a89-927a-10e0-503e-5f901bdca30f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "13033a89-927a-10e0-503e-5f901bdca30f" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>method</b>: Visual inspection <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f",
"title" : "Description",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"method" : {
"text" : "Visual inspection"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "A white to brown powder"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:8395ae1d-5064-0ab7-a297-6b20285b2230",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "8395ae1d-5064-0ab7-a297-6b20285b2230",
"text" : // Identification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"8395ae1d-5064-0ab7-a297-6b20285b2230\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "8395ae1d-5064-0ab7-a297-6b20285b2230" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: Identification by IR spectroscopy Identification by HPLC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td></tr><tr><td style=\"display: none\">*</td><td/></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230",
"title" : "Identification",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"method" : {
"text" : "Identification by IR spectroscopy Identification by HPLC"
},
"qualifiedValue" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq",
"valueString" : "Conforms with reference"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:2117208e-4185-9091-1f86-cce37b121838",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "2117208e-4185-9091-1f86-cce37b121838",
"text" : // Assay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"2117208e-4185-9091-1f86-cce37b121838\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "2117208e-4185-9091-1f86-cce37b121838" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>98-102 % w/w</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838",
"title" : "Assay",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"method" : {
"text" : "Assay by LC"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 98,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"high" : {
"value" : 102,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:d04e0f2a-6ee7-6c2e-1db8-7df394c927b8",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8",
"text" : // Impurities
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8</code></p><p><b>title</b>: Drug Substance Related Organic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Drug Substance Related Organic impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DGP-s)</span></p><p><b>method</b>: Organic impurities by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.5</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.10</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8",
"title" : "Drug Substance Related Organic impurities",
"status" : "active",
"code" : // <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq"/>
</meta>
// http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DGP-s",
"display" : "Drug Substance Related Organic impurities"
}
]
},
"method" : {
"text" : "Organic impurities by LC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 2"
}
],
"range" : {
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Impurity 3",
"_text" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq",
"valueString" : "Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data"
}
]
}
}
],
"range" : {
"high" : {
"value" : 0.5,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Any individual unspecified impurity"
}
],
"range" : {
"high" : {
"value" : 0.10,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Total impurities"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:0634020c-8729-99fc-7637-89799d7c445b",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "0634020c-8729-99fc-7637-89799d7c445b",
"text" : // Mutagenic
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"0634020c-8729-99fc-7637-89799d7c445b\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "0634020c-8729-99fc-7637-89799d7c445b" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b</code></p><p><b>title</b>: Mutagenic impurities</p><p><b>status</b>: active</p><p><b>code</b>: Mutagenic impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#MUT)</span></p><p><b>method</b>: Impurity 5 content by LC-MS <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>AppliesTo</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity - Mutagenic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td><td>?-50</td></tr></table><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b",
"title" : "Mutagenic impurities",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "MUT",
"display" : "Mutagenic impurities"
}
]
},
"method" : {
"text" : "Impurity 5 content by LC-MS"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Impurity - Mutagenic"
}
],
"range" : // could be a code
{
"high" : {
"value" : 50,
"unit" : "ppm",
"system" : "http://unitsofmeasure.org",
"code" : "[ppm]"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what impurity this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:4e67725b-20c8-158e-9d53-1810bfa58d87",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "4e67725b-20c8-158e-9d53-1810bfa58d87",
"text" : // Enantiomeric
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"4e67725b-20c8-158e-9d53-1810bfa58d87\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "4e67725b-20c8-158e-9d53-1810bfa58d87" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87</code></p><p><b>title</b>: Enantiomeric purity</p><p><b>status</b>: active</p><p><b>code</b>: Enantiomeric purity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#enantiomeric-purity)</span></p><p><b>method</b>: Enantiomeric purity by LC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>99.6-? %</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87",
"title" : "Enantiomeric purity",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "enantiomeric-purity",
"display" : "Enantiomeric purity"
}
],
"text" : "Enantiomeric purity"
},
"method" : {
"text" : "Enantiomeric purity by LC"
},
"qualifiedValue" : [
{
"range" : {
"low" : {
"value" : 99.6,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:2daba8ca-211f-4f4b-4028-16c30fe22ee8",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "2daba8ca-211f-4f4b-4028-16c30fe22ee8",
"text" : // Solvents
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"2daba8ca-211f-4f4b-4028-16c30fe22ee8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "2daba8ca-211f-4f4b-4028-16c30fe22ee8" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8</code></p><p><b>title</b>: Residual solvents</p><p><b>status</b>: active</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>method</b>: Residual solvents by headspace GC <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-0.1</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Solvent 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-2.0</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8",
"title" : "Residual solvents",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"method" : {
"text" : "Residual solvents by headspace GC"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "Solvent 1"
}
],
"range" : // could be a code
{
"high" : {
"value" : 0.1,
"unit" : "% w/w"
}
}
},
{
"appliesTo" : [
{
"text" : "Solvent 2"
}
],
"range" : {
"high" : {
"value" : 2.0,
"unit" : "% w/w"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what solvent this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:17b322fe-53ea-6c1f-521b-3b148ac05eb4",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "17b322fe-53ea-6c1f-521b-3b148ac05eb4",
"text" : // Water
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"17b322fe-53ea-6c1f-521b-3b148ac05eb4\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "17b322fe-53ea-6c1f-521b-3b148ac05eb4" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP Karl Fischer titration <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>QualifiedValues</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td>?-1.0</td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4",
"title" : "Water Content",
"status" : "active",
"code" : // http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"method" : {
"text" : "USP Karl Fischer titration"
},
"qualifiedValue" : [
{
"range" : {
"high" : {
"value" : 1.0,
"unit" : "% w/w"
}
}
}
]
}
},
{
"fullUrl" : "urn:uuid:11fcfe6b-7498-132b-2def-efae51b302d4",
"resource" : {
"resourceType" : "ObservationDefinition",
"id" : "11fcfe6b-7498-132b-2def-efae51b302d4",
"text" : // Particles
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ObservationDefinition</b><a name=\"11fcfe6b-7498-132b-2def-efae51b302d4\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ObservationDefinition "11fcfe6b-7498-132b-2def-efae51b302d4" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4</code></p><p><b>title</b>: Particle size distribution</p><p><b>status</b>: active</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>method</b>: Laser diffraction <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.9) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-319</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.5) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-145</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: D(v,0.1) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>range</b>: ?-20</p></blockquote><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PARTS)</span></td></tr></table></div>"
},
"url" : "http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4",
"title" : "Particle size distribution",
"_title" : // http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
{
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-test-comment-pq",
"valueString" : "Particle Size Distribution was included in the release specification throughout clinical development, and no longer forms a part of the commercial release specification; See Section S.4.5 Justification of Specification for data and rationale."
}
]
},
"status" : "active",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"method" : {
"text" : "Laser diffraction"
},
"qualifiedValue" : [
{
"appliesTo" : [
{
"text" : "D(v,0.9)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 319,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
},
{
"appliesTo" : [
{
"text" : "D(v,0.5)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 145,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
},
{
"appliesTo" : [
{
"text" : "D(v,0.1)"
}
],
"range" : // could be a code
{
"high" : {
"value" : 20,
"unit" : "µm",
"system" : "http://unitsofmeasure.org",
"code" : "um"
}
}
}
],
"component" : [
{
"code" : // are expected to have a component that says what solvent this one is
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PARTS",
"display" : "Particle size"
}
]
}
}
]
}
},
{
"fullUrl" : "urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1",
"resource" : {
"resourceType" : "Substance",
"id" : "87ef899b-14dd-26b7-7416-7ec1d01b62a1",
"text" : // substance-drug-pq-ex1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"87ef899b-14dd-26b7-7416-7ec1d01b62a1\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-01</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330\">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Manufacturing Process PQ</b>: <a href=\"#PlanDefinition_b30a1024-37db-a1bc-05e5-cc4596d92975\">See above (PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975)</a></p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></td></tr></table></div>"
},
"extension" : [
// was actual-batch-substance
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-01"
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq",
"valueReference" : {
"reference" : "PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975"
}
},
// PlanDefinition/plandefinition-dxpq-ex4-mnf-process
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT1"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4",
"resource" : {
"resourceType" : "Substance",
"id" : "6412c5d4-1b7d-8405-85dc-75dbaa300ea4",
"text" : // actual-batch-substance-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"6412c5d4-1b7d-8405-85dc-75dbaa300ea4\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-02</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330\">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-02"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
// could also be C185328 Stability Study?
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT2"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7",
"resource" : {
"resourceType" : "Substance",
"id" : "ef17cff1-6586-a4a4-9168-2602140548d7",
"text" : // actual-batch-substance-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Substance</b><a name=\"ef17cff1-6586-a4a4-9168-2602140548d7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Substance "ef17cff1-6586-a4a4-9168-2602140548d7" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-03</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: <a href=\"#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330\">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: id:\u00a0CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-03"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT3"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:b30a1024-37db-a1bc-05e5-cc4596d92975",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "b30a1024-37db-a1bc-05e5-cc4596d92975",
"text" : // id value="manufacturingProcess"/
// plandefinition-dxpq-ex4-mnf-process
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"b30a1024-37db-a1bc-05e5-cc4596d92975\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "b30a1024-37db-a1bc-05e5-cc4596d92975" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975</code></p><p><b>title</b>: Process 1.1</p><p><b>type</b>: Manufacturing Process <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (planType#1244566)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"#SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\">See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)</a></p></div>"
},
"url" : "http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975",
"title" : "Process 1.1",
"type" : // http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975
{
"coding" : [
{
"system" : "http://example.org/fhir/code/planType",
"code" : "1244566",
"display" : "Manufacturing Process"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "8dae93e0-048d-35a4-71ea-7c603184a130",
"text" : // substance1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"8dae93e0-048d-35a4-71ea-7c603184a130\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource SubstanceDefinition "8dae93e0-048d-35a4-71ea-7c603184a130" </p></div><p><b>manufacturer</b>: <a href=\"#Organization_3d399cbc-244e-9b5f-838b-b7daa0489330\">See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)</a></p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330",
"resource" : {
"resourceType" : "Organization",
"id" : "3d399cbc-244e-9b5f-838b-b7daa0489330",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"3d399cbc-244e-9b5f-838b-b7daa0489330\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "3d399cbc-244e-9b5f-838b-b7daa0489330" </p></div><p><b>identifier</b>: id:\u00a03003040516</p><p><b>name</b>: AAA Molybdenum Products, Inc.</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
// FDA establishment identifier
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b08",
"text" : // testing lab
// 378fbe5f-5926-3a5c-4c64-5428df877b08
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b08\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" </p></div><p><b>name</b>: Testing Lab</p></div>"
},
"name" : "Testing Lab"
}
},
{
"fullUrl" : "urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006",
"resource" : {
"resourceType" : "DiagnosticReport",
"id" : "batchAnalysisReport",
"text" : // ideally this wants a subject, but it can only be a Medication (batch) and we have multiple.
however the observations themselves do have subjects
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: DiagnosticReport</b><a name=\"batchAnalysisReport\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource DiagnosticReport "batchAnalysisReport" </p></div><p><b>Triggered by</b>: <a href=\"#PlanDefinition_2038e4c7-22b8-4c56-2d28-6c077648763f\">See above (PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Batch Analysis Report <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-reportType-local-pq.html\">CodeSystem - Report Type</a>#Batch Analysis Report)</span></p><p><b>effective</b>: 2020-12</p><p><b>result</b>: </p><ul><li><a href=\"#Observation_81f552f9-8458-3cf4-8379-eea5417a9de2\">See above (Observation/81f552f9-8458-3cf4-8379-eea5417a9de2)</a></li><li><a href=\"#Observation_50bf6f69-a3f5-678b-469b-c5df5cca4c86\">See above (Observation/50bf6f69-a3f5-678b-469b-c5df5cca4c86)</a></li><li><a href=\"#Observation_145fd3b7-3678-867f-4298-a6c781b86de3\">See above (Observation/145fd3b7-3678-867f-4298-a6c781b86de3)</a></li><li><a href=\"#Observation_55c89944-60d1-4eea-a2c3-6c53e3622bc5\">See above (Observation/55c89944-60d1-4eea-a2c3-6c53e3622bc5)</a></li><li><a href=\"#Observation_adb51ab6-00a9-1078-69e5-d32c025a857c\">See above (Observation/adb51ab6-00a9-1078-69e5-d32c025a857c)</a></li><li><a href=\"#Observation_916a0ae2-9c43-72f0-a22a-c5f8ce902125\">See above (Observation/916a0ae2-9c43-72f0-a22a-c5f8ce902125)</a></li><li><a href=\"#Observation_6deb4306-1193-24ae-a565-f73225652bdd\">See above (Observation/6deb4306-1193-24ae-a565-f73225652bdd)</a></li><li><a href=\"#Observation_f6aabd2f-5902-57e7-6126-eccd9158a5b5\">See above (Observation/f6aabd2f-5902-57e7-6126-eccd9158a5b5)</a></li><li><a href=\"#Observation_32f598e4-a0e0-98dc-41dd-0f8397f953ad\">See above (Observation/32f598e4-a0e0-98dc-41dd-0f8397f953ad)</a></li><li><a href=\"#Observation_02d9e6be-833c-1c6d-a64a-baa3935c959d\">See above (Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d)</a></li><li><a href=\"#Observation_d3e572b7-14fd-744b-4123-58741d75571e\">See above (Observation/d3e572b7-14fd-744b-4123-58741d75571e)</a></li><li><a href=\"#Observation_fe6ca484-a755-9a0b-a074-b6ee0a907ff8\">See above (Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8)</a></li><li><a href=\"#Observation_da92c71f-a12a-1980-11a3-80e3d1852244\">See above (Observation/da92c71f-a12a-1980-11a3-80e3d1852244)</a></li><li><a href=\"#Observation_8bf75da1-9221-66fe-6725-c64cb45a57e6\">See above (Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6)</a></li><li><a href=\"#Observation_31bfeff4-4a7d-3be5-878e-fb674d3d5487\">See above (Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487)</a></li><li><a href=\"#Observation_732237a9-4b3b-27cc-99ca-6b913e622a29\">See above (Observation/732237a9-4b3b-27cc-99ca-6b913e622a29)</a></li><li><a href=\"#Observation_52afbeb4-4958-a275-a0ca-d70b2b5240ec\">See above (Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec)</a></li><li><a href=\"#Observation_7fc395b1-59e4-78be-0512-cf92133c0fac\">See above (Observation/7fc395b1-59e4-78be-0512-cf92133c0fac)</a></li><li><a href=\"#Observation_9c98bd8a-7dda-2f01-0dbd-8c60b60e8572\">See above (Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572)</a></li><li><a href=\"#Observation_97b16ff8-8e0f-915a-9d65-7fab108f40c2\">See above (Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2)</a></li><li><a href=\"#Observation_0244eafe-3126-909b-7d8d-4253f45f525c\">See above (Observation/0244eafe-3126-909b-7d8d-4253f45f525c)</a></li><li><a href=\"#Observation_10b80cbd-45d3-9be1-63b9-29f04b47376c\">See above (Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c)</a></li><li><a href=\"#Observation_84f015ac-9572-324f-8013-0b999cc95bbd\">See above (Observation/84f015ac-9572-324f-8013-0b999cc95bbd)</a></li><li><a href=\"#Observation_987daeaa-4c2a-72b7-780f-4a9403163a3e\">See above (Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e)</a></li><li><a href=\"#Observation_02d9e6be-833c-1c6d-a64a-baa3935c959d\">See above (Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d)</a></li><li><a href=\"#Observation_d3e572b7-14fd-744b-4123-58741d75571e\">See above (Observation/d3e572b7-14fd-744b-4123-58741d75571e)</a></li><li><a href=\"#Observation_fe6ca484-a755-9a0b-a074-b6ee0a907ff8\">See above (Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8)</a></li><li><a href=\"#Observation_da92c71f-a12a-1980-11a3-80e3d1852244\">See above (Observation/da92c71f-a12a-1980-11a3-80e3d1852244)</a></li><li><a href=\"#Observation_8bf75da1-9221-66fe-6725-c64cb45a57e6\">See above (Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6)</a></li><li><a href=\"#Observation_31bfeff4-4a7d-3be5-878e-fb674d3d5487\">See above (Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487)</a></li><li><a href=\"#Observation_732237a9-4b3b-27cc-99ca-6b913e622a29\">See above (Observation/732237a9-4b3b-27cc-99ca-6b913e622a29)</a></li><li><a href=\"#Observation_52afbeb4-4958-a275-a0ca-d70b2b5240ec\">See above (Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec)</a></li><li><a href=\"#Observation_7fc395b1-59e4-78be-0512-cf92133c0fac\">See above (Observation/7fc395b1-59e4-78be-0512-cf92133c0fac)</a></li><li><a href=\"#Observation_9c98bd8a-7dda-2f01-0dbd-8c60b60e8572\">See above (Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572)</a></li><li><a href=\"#Observation_97b16ff8-8e0f-915a-9d65-7fab108f40c2\">See above (Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2)</a></li><li><a href=\"#Observation_0244eafe-3126-909b-7d8d-4253f45f525c\">See above (Observation/0244eafe-3126-909b-7d8d-4253f45f525c)</a></li><li><a href=\"#Observation_10b80cbd-45d3-9be1-63b9-29f04b47376c\">See above (Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c)</a></li><li><a href=\"#Observation_84f015ac-9572-324f-8013-0b999cc95bbd\">See above (Observation/84f015ac-9572-324f-8013-0b999cc95bbd)</a></li><li><a href=\"#Observation_987daeaa-4c2a-72b7-780f-4a9403163a3e\">See above (Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e)</a></li><li><a href=\"#Observation_ff26533d-88a8-7f18-a275-42dc1373a388\">See above (Observation/ff26533d-88a8-7f18-a275-42dc1373a388)</a></li><li><a href=\"#Observation_c99666d2-7962-9a71-58f6-7b2e5aa662f5\">See above (Observation/c99666d2-7962-9a71-58f6-7b2e5aa662f5)</a></li><li><a href=\"#Observation_c18e21d3-7113-4d08-4ff3-0c9718596f64\">See above (Observation/c18e21d3-7113-4d08-4ff3-0c9718596f64)</a></li><li><a href=\"#Observation_66fdac46-2a6b-a66f-891b-8dcf67cc46c7\">See above (Observation/66fdac46-2a6b-a66f-891b-8dcf67cc46c7)</a></li><li><a href=\"#Observation_8306cfc5-158f-1a53-a683-048b226060d9\">See above (Observation/8306cfc5-158f-1a53-a683-048b226060d9)</a></li><li><a href=\"#Observation_fc49ad55-07d1-997d-6695-bbff44746e75\">See above (Observation/fc49ad55-07d1-997d-6695-bbff44746e75)</a></li><li><a href=\"#Observation_f8160692-a7a8-3fa6-9f35-e7df35f51ac0\">See above (Observation/f8160692-a7a8-3fa6-9f35-e7df35f51ac0)</a></li><li><a href=\"#Observation_a531aee9-4c21-06af-352c-a3615b5d957e\">See above (Observation/a531aee9-4c21-06af-352c-a3615b5d957e)</a></li><li><a href=\"#Observation_033ce81d-5f0d-7a3e-93d3-fc64e122a1fd\">See above (Observation/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd)</a></li><li><a href=\"#Observation_ba8a182e-8571-6cbd-047b-612735d599d2\">See above (Observation/ba8a182e-8571-6cbd-047b-612735d599d2)</a></li><li><a href=\"#Observation_0b5b94cc-7a1a-4ada-66c7-954ceb528d67\">See above (Observation/0b5b94cc-7a1a-4ada-66c7-954ceb528d67)</a></li><li><a href=\"#Observation_6afaacee-11a6-58b2-47df-5f79722c66ac\">See above (Observation/6afaacee-11a6-58b2-47df-5f79722c66ac)</a></li><li><a href=\"#Observation_c2644a86-1684-286e-00e2-dcaf907a8970\">See above (Observation/c2644a86-1684-286e-00e2-dcaf907a8970)</a></li><li><a href=\"#Observation_cb5f6872-6eeb-727a-7c33-f2c438581a1c\">See above (Observation/cb5f6872-6eeb-727a-7c33-f2c438581a1c)</a></li><li><a href=\"#Observation_7faaf980-7c10-7b9a-9572-1bacd485824e\">See above (Observation/7faaf980-7c10-7b9a-9572-1bacd485824e)</a></li><li><a href=\"#Observation_e4d2118a-8562-9eb1-2c14-4e145d2a95fc\">See above (Observation/e4d2118a-8562-9eb1-2c14-4e145d2a95fc)</a></li><li><a href=\"#Observation_ec078717-9512-4db4-77c6-2c7e29d213a6\">See above (Observation/ec078717-9512-4db4-77c6-2c7e29d213a6)</a></li><li><a href=\"#Observation_05cfb495-2580-561a-688d-ce6ea24c8962\">See above (Observation/05cfb495-2580-561a-688d-ce6ea24c8962)</a></li><li><a href=\"#Observation_d2a60ae5-96b4-3d13-38da-729c652347a3\">See above (Observation/d2a60ae5-96b4-3d13-38da-729c652347a3)</a></li><li><a href=\"#Observation_c3f51325-2f5f-194c-919b-2219ee1f5c45\">See above (Observation/c3f51325-2f5f-194c-919b-2219ee1f5c45)</a></li><li><a href=\"#Observation_e9d89693-11b1-13ed-5cde-606fc1b8372c\">See above (Observation/e9d89693-11b1-13ed-5cde-606fc1b8372c)</a></li><li><a href=\"#Observation_2659b000-96e2-1b8b-129b-0c00e1074b0f\">See above (Observation/2659b000-96e2-1b8b-129b-0c00e1074b0f)</a></li><li><a href=\"#Observation_10b47328-36fa-343d-5699-5b32b30a6d33\">See above (Observation/10b47328-36fa-343d-5699-5b32b30a6d33)</a></li><li><a href=\"#Observation_e6780766-317a-382f-92d2-79825f506cc5\">See above (Observation/e6780766-317a-382f-92d2-79825f506cc5)</a></li></ul><p><b>conclusion</b>: The samples have been assessed and the conclusion is...</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy",
"valueReference" : {
"reference" : "PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f"
}
}
],
"status" : "final",
"code" : // PlanDefinition/specificationProtocol
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-reportType-local-pq",
"code" : "Batch Analysis Report",
"display" : "Batch Analysis Report"
}
]
},
"effectiveDateTime" : "2020-12",
"result" : [
// start of stability test
{
"reference" : "Observation/81f552f9-8458-3cf4-8379-eea5417a9de2"
},
// Observation/observation-test-result-drug-pq-ex2
{
"reference" : "Observation/50bf6f69-a3f5-678b-469b-c5df5cca4c86"
},
// Observation/observationDescription2
{
"reference" : "Observation/145fd3b7-3678-867f-4298-a6c781b86de3"
},
// Observation/observationDescription3
{
"reference" : "Observation/55c89944-60d1-4eea-a2c3-6c53e3622bc5"
},
// Observation/observationIdentification
{
"reference" : "Observation/adb51ab6-00a9-1078-69e5-d32c025a857c"
},
// Observation/observationIdentification2
{
"reference" : "Observation/916a0ae2-9c43-72f0-a22a-c5f8ce902125"
},
// Observation/observationIdentification3
{
"reference" : "Observation/6deb4306-1193-24ae-a565-f73225652bdd"
},
// Observation/observationAssay
{
"reference" : "Observation/f6aabd2f-5902-57e7-6126-eccd9158a5b5"
},
// Observation/observationAssay2
{
"reference" : "Observation/32f598e4-a0e0-98dc-41dd-0f8397f953ad"
},
// Observation/observationAssay3
{
"reference" : "Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d"
},
// Observation/observationDegradation-imp1
{
"reference" : "Observation/d3e572b7-14fd-744b-4123-58741d75571e"
},
// Observation/observationDegradation-imp1-2
{
"reference" : "Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8"
},
// Observation/observationDegradation-imp1-3
{
"reference" : "Observation/da92c71f-a12a-1980-11a3-80e3d1852244"
},
// Observation/observationDegradation-imp2
{
"reference" : "Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6"
},
// Observation/observationDegradation-imp2-2
{
"reference" : "Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487"
},
// Observation/observationDegradation-imp2-3
{
"reference" : "Observation/732237a9-4b3b-27cc-99ca-6b913e622a29"
},
// Observation/observationDegradation-imp3
{
"reference" : "Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec"
},
// Observation/observationDegradation-imp3-2
{
"reference" : "Observation/7fc395b1-59e4-78be-0512-cf92133c0fac"
},
// Observation/observationDegradation-imp3-3
{
"reference" : "Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572"
},
// Observation/observationDegradation-imp-unspecified
{
"reference" : "Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2"
},
// Observation/observationDegradation-imp-unspecified-2
{
"reference" : "Observation/0244eafe-3126-909b-7d8d-4253f45f525c"
},
// Observation/observationDegradation-imp-unspecified-3
{
"reference" : "Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c"
},
// Observation/observationDegradation-imp-total
{
"reference" : "Observation/84f015ac-9572-324f-8013-0b999cc95bbd"
},
// Observation/observationDegradation-imp-total-2
{
"reference" : "Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e"
},
// Observation/observationDegradation-imp-total-3
{
"reference" : "Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d"
},
// Observation/observationDegradation-imp1
{
"reference" : "Observation/d3e572b7-14fd-744b-4123-58741d75571e"
},
// Observation/observationDegradation-imp1-2
{
"reference" : "Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8"
},
// Observation/observationDegradation-imp1-3
{
"reference" : "Observation/da92c71f-a12a-1980-11a3-80e3d1852244"
},
// Observation/observationDegradation-imp2
{
"reference" : "Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6"
},
// Observation/observationDegradation-imp2-2
{
"reference" : "Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487"
},
// Observation/observationDegradation-imp2-3
{
"reference" : "Observation/732237a9-4b3b-27cc-99ca-6b913e622a29"
},
// Observation/observationDegradation-imp3
{
"reference" : "Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec"
},
// Observation/observationDegradation-imp3-2
{
"reference" : "Observation/7fc395b1-59e4-78be-0512-cf92133c0fac"
},
// Observation/observationDegradation-imp3-3
{
"reference" : "Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572"
},
// Observation/observationDegradation-imp-unspecified
{
"reference" : "Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2"
},
// Observation/observationDegradation-imp-unspecified-2
{
"reference" : "Observation/0244eafe-3126-909b-7d8d-4253f45f525c"
},
// Observation/observationDegradation-imp-unspecified-3
{
"reference" : "Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c"
},
// Observation/observationDegradation-imp-total
{
"reference" : "Observation/84f015ac-9572-324f-8013-0b999cc95bbd"
},
// Observation/observationDegradation-imp-total-2
{
"reference" : "Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e"
},
// Observation/observationDegradation-imp-total-3
{
"reference" : "Observation/ff26533d-88a8-7f18-a275-42dc1373a388"
},
// Observation/observationMutagenic
{
"reference" : "Observation/c99666d2-7962-9a71-58f6-7b2e5aa662f5"
},
// Observation/observationMutagenic2
{
"reference" : "Observation/c18e21d3-7113-4d08-4ff3-0c9718596f64"
},
// Observation/observationMutagenic3
{
"reference" : "Observation/66fdac46-2a6b-a66f-891b-8dcf67cc46c7"
},
// Observation/observationEnantiomericPurity
{
"reference" : "Observation/8306cfc5-158f-1a53-a683-048b226060d9"
},
// Observation/observationEnantiomericPurity2
{
"reference" : "Observation/fc49ad55-07d1-997d-6695-bbff44746e75"
},
// Observation/observationEnantiomericPurity3
{
"reference" : "Observation/f8160692-a7a8-3fa6-9f35-e7df35f51ac0"
},
// Observation/observationSolvents-sol1
{
"reference" : "Observation/a531aee9-4c21-06af-352c-a3615b5d957e"
},
// Observation/observationSolvents-sol1-2
{
"reference" : "Observation/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"
},
// Observation/observationSolvents-sol1-3
{
"reference" : "Observation/ba8a182e-8571-6cbd-047b-612735d599d2"
},
// Observation/observationSolvents-sol2
{
"reference" : "Observation/0b5b94cc-7a1a-4ada-66c7-954ceb528d67"
},
// Observation/observationSolvents-sol2-2
{
"reference" : "Observation/6afaacee-11a6-58b2-47df-5f79722c66ac"
},
// Observation/observationSolvents-sol2-3
{
"reference" : "Observation/c2644a86-1684-286e-00e2-dcaf907a8970"
},
// Observation/observationWater
{
"reference" : "Observation/cb5f6872-6eeb-727a-7c33-f2c438581a1c"
},
// Observation/observationWater2
{
"reference" : "Observation/7faaf980-7c10-7b9a-9572-1bacd485824e"
},
// Observation/observationWater3
{
"reference" : "Observation/e4d2118a-8562-9eb1-2c14-4e145d2a95fc"
},
// Observation/observationParticleSize-size1
{
"reference" : "Observation/ec078717-9512-4db4-77c6-2c7e29d213a6"
},
// Observation/observationParticleSize-size1-2
{
"reference" : "Observation/05cfb495-2580-561a-688d-ce6ea24c8962"
},
// Observation/observationParticleSize-size1-3
{
"reference" : "Observation/d2a60ae5-96b4-3d13-38da-729c652347a3"
},
// Observation/observationParticleSize-size2
{
"reference" : "Observation/c3f51325-2f5f-194c-919b-2219ee1f5c45"
},
// Observation/observationParticleSize-size2-2
{
"reference" : "Observation/e9d89693-11b1-13ed-5cde-606fc1b8372c"
},
// Observation/observationParticleSize-size2-3
{
"reference" : "Observation/2659b000-96e2-1b8b-129b-0c00e1074b0f"
},
// Observation/observationParticleSize-size3
{
"reference" : "Observation/10b47328-36fa-343d-5699-5b32b30a6d33"
},
// Observation/observationParticleSize-size3-2
{
"reference" : "Observation/e6780766-317a-382f-92d2-79825f506cc5"
}
],
"conclusion" : "The samples have been assessed and the conclusion is..."
}
},
// Observation/observationParticleSize-size3-3
{
"fullUrl" : "urn:uuid:81f552f9-8458-3cf4-8379-eea5417a9de2",
"resource" : {
"resourceType" : "Observation",
"id" : "81f552f9-8458-3cf4-8379-eea5417a9de2",
"text" : // observation-test-result-drug-pq-ex2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"81f552f9-8458-3cf4-8379-eea5417a9de2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "81f552f9-8458-3cf4-8379-eea5417a9de2" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_13033a89-927a-10e0-503e-5f901bdca30f\">See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Pass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : // was observationDescription
// <meta>
<profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq"/>
</meta>
{
"reference" : "ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Pass"
}
}
},
{
"fullUrl" : "urn:uuid:50bf6f69-a3f5-678b-469b-c5df5cca4c86",
"resource" : {
"resourceType" : "Observation",
"id" : "50bf6f69-a3f5-678b-469b-c5df5cca4c86",
"text" : // observationDescription2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"50bf6f69-a3f5-678b-469b-c5df5cca4c86\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "50bf6f69-a3f5-678b-469b-c5df5cca4c86" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_13033a89-927a-10e0-503e-5f901bdca30f\">See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Pass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Pass"
}
}
},
{
"fullUrl" : "urn:uuid:145fd3b7-3678-867f-4298-a6c781b86de3",
"resource" : {
"resourceType" : "Observation",
"id" : "145fd3b7-3678-867f-4298-a6c781b86de3",
"text" : // observationDescription3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"145fd3b7-3678-867f-4298-a6c781b86de3\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "145fd3b7-3678-867f-4298-a6c781b86de3" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_13033a89-927a-10e0-503e-5f901bdca30f\">See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)</a></p><p><b>status</b>: final</p><p><b>code</b>: Description <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#DESC)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Pass <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f"
},
"status" : "final",
"code" : // ObservationDefinition/Description
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "DESC",
"display" : "Description"
}
],
"text" : "Description"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Pass"
}
}
},
{
"fullUrl" : "urn:uuid:55c89944-60d1-4eea-a2c3-6c53e3622bc5",
"resource" : {
"resourceType" : "Observation",
"id" : "55c89944-60d1-4eea-a2c3-6c53e3622bc5",
"text" : // observationIdentification
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"55c89944-60d1-4eea-a2c3-6c53e3622bc5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "55c89944-60d1-4eea-a2c3-6c53e3622bc5" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8395ae1d-5064-0ab7-a297-6b20285b2230\">See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conforms <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Conforms"
}
}
},
{
"fullUrl" : "urn:uuid:adb51ab6-00a9-1078-69e5-d32c025a857c",
"resource" : {
"resourceType" : "Observation",
"id" : "adb51ab6-00a9-1078-69e5-d32c025a857c",
"text" : // observationIdentification2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"adb51ab6-00a9-1078-69e5-d32c025a857c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "adb51ab6-00a9-1078-69e5-d32c025a857c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8395ae1d-5064-0ab7-a297-6b20285b2230\">See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Does not conform <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Does not conform"
}
}
},
{
"fullUrl" : "urn:uuid:916a0ae2-9c43-72f0-a22a-c5f8ce902125",
"resource" : {
"resourceType" : "Observation",
"id" : "916a0ae2-9c43-72f0-a22a-c5f8ce902125",
"text" : // observationIdentification3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"916a0ae2-9c43-72f0-a22a-c5f8ce902125\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "916a0ae2-9c43-72f0-a22a-c5f8ce902125" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_8395ae1d-5064-0ab7-a297-6b20285b2230\">See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)</a></p><p><b>status</b>: final</p><p><b>code</b>: Identification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IDT)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: Conforms <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230"
},
"status" : "final",
"code" : // ObservationDefinition/Identification
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IDT",
"display" : "Identification"
}
],
"text" : "Identification"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueCodeableConcept" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"text" : "Conforms"
}
}
},
{
"fullUrl" : "urn:uuid:6deb4306-1193-24ae-a565-f73225652bdd",
"resource" : {
"resourceType" : "Observation",
"id" : "6deb4306-1193-24ae-a565-f73225652bdd",
"text" : // observationAssay
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"6deb4306-1193-24ae-a565-f73225652bdd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "6deb4306-1193-24ae-a565-f73225652bdd" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2117208e-4185-9091-1f86-cce37b121838\">See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 94 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 94,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%"
}
]
}
},
{
"fullUrl" : "urn:uuid:f6aabd2f-5902-57e7-6126-eccd9158a5b5",
"resource" : {
"resourceType" : "Observation",
"id" : "f6aabd2f-5902-57e7-6126-eccd9158a5b5",
"text" : // observationAssay2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f6aabd2f-5902-57e7-6126-eccd9158a5b5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f6aabd2f-5902-57e7-6126-eccd9158a5b5" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2117208e-4185-9091-1f86-cce37b121838\">See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 95 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 95,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%"
}
]
}
},
{
"fullUrl" : "urn:uuid:32f598e4-a0e0-98dc-41dd-0f8397f953ad",
"resource" : {
"resourceType" : "Observation",
"id" : "32f598e4-a0e0-98dc-41dd-0f8397f953ad",
"text" : // observationAssay3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"32f598e4-a0e0-98dc-41dd-0f8397f953ad\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "32f598e4-a0e0-98dc-41dd-0f8397f953ad" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2117208e-4185-9091-1f86-cce37b121838\">See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)</a></p><p><b>status</b>: final</p><p><b>code</b>: Assay <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 96 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838"
},
"status" : "final",
"code" : // ObservationDefinition/Assay
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "ASSAY",
"display" : "Assay"
}
],
"text" : "Assay"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 96,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%"
}
]
}
},
{
"fullUrl" : "urn:uuid:02d9e6be-833c-1c6d-a64a-baa3935c959d",
"resource" : {
"resourceType" : "Observation",
"id" : "02d9e6be-833c-1c6d-a64a-baa3935c959d",
"text" : // observationDegradation-imp1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"02d9e6be-833c-1c6d-a64a-baa3935c959d\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "02d9e6be-833c-1c6d-a64a-baa3935c959d" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:d3e572b7-14fd-744b-4123-58741d75571e",
"resource" : {
"resourceType" : "Observation",
"id" : "d3e572b7-14fd-744b-4123-58741d75571e",
"text" : // observationDegradation-imp1-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"d3e572b7-14fd-744b-4123-58741d75571e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "d3e572b7-14fd-744b-4123-58741d75571e" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.4 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:fe6ca484-a755-9a0b-a074-b6ee0a907ff8",
"resource" : {
"resourceType" : "Observation",
"id" : "fe6ca484-a755-9a0b-a074-b6ee0a907ff8",
"text" : // observationDegradation-imp1-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"fe6ca484-a755-9a0b-a074-b6ee0a907ff8\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "fe6ca484-a755-9a0b-a074-b6ee0a907ff8" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:da92c71f-a12a-1980-11a3-80e3d1852244",
"resource" : {
"resourceType" : "Observation",
"id" : "da92c71f-a12a-1980-11a3-80e3d1852244",
"text" : // observationDegradation-imp2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"da92c71f-a12a-1980-11a3-80e3d1852244\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "da92c71f-a12a-1980-11a3-80e3d1852244" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6",
"resource" : {
"resourceType" : "Observation",
"id" : "8bf75da1-9221-66fe-6725-c64cb45a57e6",
"text" : // observationDegradation-imp2-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"8bf75da1-9221-66fe-6725-c64cb45a57e6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.4 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:31bfeff4-4a7d-3be5-878e-fb674d3d5487",
"resource" : {
"resourceType" : "Observation",
"id" : "31bfeff4-4a7d-3be5-878e-fb674d3d5487",
"text" : // observationDegradation-imp2-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"31bfeff4-4a7d-3be5-878e-fb674d3d5487\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "31bfeff4-4a7d-3be5-878e-fb674d3d5487" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:732237a9-4b3b-27cc-99ca-6b913e622a29",
"resource" : {
"resourceType" : "Observation",
"id" : "732237a9-4b3b-27cc-99ca-6b913e622a29",
"text" : // observationDegradation-imp3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"732237a9-4b3b-27cc-99ca-6b913e622a29\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "732237a9-4b3b-27cc-99ca-6b913e622a29" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:52afbeb4-4958-a275-a0ca-d70b2b5240ec",
"resource" : {
"resourceType" : "Observation",
"id" : "52afbeb4-4958-a275-a0ca-d70b2b5240ec",
"text" : // observationDegradation-imp3-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"52afbeb4-4958-a275-a0ca-d70b2b5240ec\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "52afbeb4-4958-a275-a0ca-d70b2b5240ec" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:7fc395b1-59e4-78be-0512-cf92133c0fac",
"resource" : {
"resourceType" : "Observation",
"id" : "7fc395b1-59e4-78be-0512-cf92133c0fac",
"text" : // observationDegradation-imp3-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"7fc395b1-59e4-78be-0512-cf92133c0fac\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "7fc395b1-59e4-78be-0512-cf92133c0fac" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity 3"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:9c98bd8a-7dda-2f01-0dbd-8c60b60e8572",
"resource" : {
"resourceType" : "Observation",
"id" : "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572",
"text" : // observationDegradation-imp-unspecified
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"9c98bd8a-7dda-2f01-0dbd-8c60b60e8572\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any individual unspecified impurity"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:97b16ff8-8e0f-915a-9d65-7fab108f40c2",
"resource" : {
"resourceType" : "Observation",
"id" : "97b16ff8-8e0f-915a-9d65-7fab108f40c2",
"text" : // observationDegradation-imp-unspecified-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"97b16ff8-8e0f-915a-9d65-7fab108f40c2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "97b16ff8-8e0f-915a-9d65-7fab108f40c2" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any individual unspecified impurity"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:0244eafe-3126-909b-7d8d-4253f45f525c",
"resource" : {
"resourceType" : "Observation",
"id" : "0244eafe-3126-909b-7d8d-4253f45f525c",
"text" : // observationDegradation-imp-unspecified-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"0244eafe-3126-909b-7d8d-4253f45f525c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "0244eafe-3126-909b-7d8d-4253f45f525c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Any individual unspecified impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Any individual unspecified impurity"
}
}
]
}
},
// could have the code of an imw substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:10b80cbd-45d3-9be1-63b9-29f04b47376c",
"resource" : {
"resourceType" : "Observation",
"id" : "10b80cbd-45d3-9be1-63b9-29f04b47376c",
"text" : // observationDegradation-imp-total
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"10b80cbd-45d3-9be1-63b9-29f04b47376c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "10b80cbd-45d3-9be1-63b9-29f04b47376c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.02 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.02,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total impurities"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:84f015ac-9572-324f-8013-0b999cc95bbd",
"resource" : {
"resourceType" : "Observation",
"id" : "84f015ac-9572-324f-8013-0b999cc95bbd",
"text" : // observationDegradation-imp-total-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"84f015ac-9572-324f-8013-0b999cc95bbd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "84f015ac-9572-324f-8013-0b999cc95bbd" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.02 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.02,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total impurities"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:987daeaa-4c2a-72b7-780f-4a9403163a3e",
"resource" : {
"resourceType" : "Observation",
"id" : "987daeaa-4c2a-72b7-780f-4a9403163a3e",
"text" : // observationDegradation-imp-total-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"987daeaa-4c2a-72b7-780f-4a9403163a3e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "987daeaa-4c2a-72b7-780f-4a9403163a3e" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_d04e0f2a-6ee7-6c2e-1db8-7df394c927b8\">See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#Impurities)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.02 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Total impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
},
"status" : "final",
"code" : // ObservationDefinition/Impurities
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "Impurities",
"display" : "Impurities"
}
],
"text" : "Impurities"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.02,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Total impurities"
}
}
]
}
},
// could have the code of an imr substance, or could have an extension to point to it as a resource
{
"fullUrl" : "urn:uuid:ff26533d-88a8-7f18-a275-42dc1373a388",
"resource" : {
"resourceType" : "Observation",
"id" : "ff26533d-88a8-7f18-a275-42dc1373a388",
"text" : // observationMutagenic
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"ff26533d-88a8-7f18-a275-42dc1373a388\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "ff26533d-88a8-7f18-a275-42dc1373a388" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_0634020c-8729-99fc-7637-89799d7c445b\">See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Mutagenic impurities <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#MUT)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 20 ppm<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code [ppm] = '[ppm]')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>Impurity - Mutagenic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b"
},
"status" : "final",
"code" : // ObservationDefinition/Mutagenic
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "MUT",
"display" : "Mutagenic impurities"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 20,
"unit" : "ppm",
"system" : "http://unitsofmeasure.org",
"code" : "[ppm]"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "Impurity - Mutagenic"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:c99666d2-7962-9a71-58f6-7b2e5aa662f5",
"resource" : {
"resourceType" : "Observation",
"id" : "c99666d2-7962-9a71-58f6-7b2e5aa662f5",
"text" : // observationMutagenic2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"c99666d2-7962-9a71-58f6-7b2e5aa662f5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "c99666d2-7962-9a71-58f6-7b2e5aa662f5" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_0634020c-8729-99fc-7637-89799d7c445b\">See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Mutagenic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#MUT "Mutagenic impurities")</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 22 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b"
},
"status" : "final",
"code" : // ObservationDefinition/Mutagenic
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "MUT",
"display" : "Mutagenic impurities"
}
],
"text" : "Mutagenic"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 22,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:c18e21d3-7113-4d08-4ff3-0c9718596f64",
"resource" : {
"resourceType" : "Observation",
"id" : "c18e21d3-7113-4d08-4ff3-0c9718596f64",
"text" : // observationMutagenic3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"c18e21d3-7113-4d08-4ff3-0c9718596f64\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "c18e21d3-7113-4d08-4ff3-0c9718596f64" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_0634020c-8729-99fc-7637-89799d7c445b\">See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)</a></p><p><b>status</b>: final</p><p><b>code</b>: Mutagenic <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#MUT "Mutagenic impurities")</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 18 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b"
},
"status" : "final",
"code" : // ObservationDefinition/Mutagenic
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "MUT",
"display" : "Mutagenic impurities"
}
],
"text" : "Mutagenic"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 18,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:66fdac46-2a6b-a66f-891b-8dcf67cc46c7",
"resource" : {
"resourceType" : "Observation",
"id" : "66fdac46-2a6b-a66f-891b-8dcf67cc46c7",
"text" : // observationEnantiomericPurity
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"66fdac46-2a6b-a66f-891b-8dcf67cc46c7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "66fdac46-2a6b-a66f-891b-8dcf67cc46c7" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_4e67725b-20c8-158e-9d53-1810bfa58d87\">See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)</a></p><p><b>status</b>: final</p><p><b>code</b>: Enantiomeric purity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#enantiomeric-purity)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 91.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87"
},
"status" : "final",
"code" : // ObservationDefinition/Enantiomeric
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "enantiomeric-purity",
"display" : "Enantiomeric purity"
}
],
"text" : "Enantiomeric purity"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 91.5,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%"
}
]
}
},
{
"fullUrl" : "urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9",
"resource" : {
"resourceType" : "Observation",
"id" : "8306cfc5-158f-1a53-a683-048b226060d9",
"text" : // observationEnantiomericPurity2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"8306cfc5-158f-1a53-a683-048b226060d9\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "8306cfc5-158f-1a53-a683-048b226060d9" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_4e67725b-20c8-158e-9d53-1810bfa58d87\">See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)</a></p><p><b>status</b>: final</p><p><b>code</b>: Enantiomeric purity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#enantiomeric-purity)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 91.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87"
},
"status" : "final",
"code" : // ObservationDefinition/Enantiomeric
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "enantiomeric-purity",
"display" : "Enantiomeric purity"
}
],
"text" : "Enantiomeric purity"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 91.5,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%"
}
]
}
},
{
"fullUrl" : "urn:uuid:fc49ad55-07d1-997d-6695-bbff44746e75",
"resource" : {
"resourceType" : "Observation",
"id" : "fc49ad55-07d1-997d-6695-bbff44746e75",
"text" : // observationEnantiomericPurity3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"fc49ad55-07d1-997d-6695-bbff44746e75\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "fc49ad55-07d1-997d-6695-bbff44746e75" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_4e67725b-20c8-158e-9d53-1810bfa58d87\">See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)</a></p><p><b>status</b>: final</p><p><b>code</b>: Enantiomeric purity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#enantiomeric-purity)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 91.5 %<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><p><b>note</b>: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.</p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87"
},
"status" : "final",
"code" : // ObservationDefinition/Enantiomeric
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "enantiomeric-purity",
"display" : "Enantiomeric purity"
}
],
"text" : "Enantiomeric purity"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 91.5,
"unit" : "%",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"note" : [
{
"text" : "Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use."
}
]
}
},
{
"fullUrl" : "urn:uuid:f8160692-a7a8-3fa6-9f35-e7df35f51ac0",
"resource" : {
"resourceType" : "Observation",
"id" : "f8160692-a7a8-3fa6-9f35-e7df35f51ac0",
"text" : // observationSolvents-sol1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"f8160692-a7a8-3fa6-9f35-e7df35f51ac0\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "f8160692-a7a8-3fa6-9f35-e7df35f51ac0" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:a531aee9-4c21-06af-352c-a3615b5d957e",
"resource" : {
"resourceType" : "Observation",
"id" : "a531aee9-4c21-06af-352c-a3615b5d957e",
"text" : // observationSolvents-sol1-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"a531aee9-4c21-06af-352c-a3615b5d957e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "a531aee9-4c21-06af-352c-a3615b5d957e" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd",
"resource" : {
"resourceType" : "Observation",
"id" : "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd",
"text" : // observationSolvents-sol1-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"033ce81d-5f0d-7a3e-93d3-fc64e122a1fd\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 1 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 1"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:ba8a182e-8571-6cbd-047b-612735d599d2",
"resource" : {
"resourceType" : "Observation",
"id" : "ba8a182e-8571-6cbd-047b-612735d599d2",
"text" : // observationSolvents-sol2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"ba8a182e-8571-6cbd-047b-612735d599d2\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "ba8a182e-8571-6cbd-047b-612735d599d2" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1.4 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:0b5b94cc-7a1a-4ada-66c7-954ceb528d67",
"resource" : {
"resourceType" : "Observation",
"id" : "0b5b94cc-7a1a-4ada-66c7-954ceb528d67",
"text" : // observationSolvents-sol2-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"0b5b94cc-7a1a-4ada-66c7-954ceb528d67\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "0b5b94cc-7a1a-4ada-66c7-954ceb528d67" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:6afaacee-11a6-58b2-47df-5f79722c66ac",
"resource" : {
"resourceType" : "Observation",
"id" : "6afaacee-11a6-58b2-47df-5f79722c66ac",
"text" : // observationSolvents-sol2-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"6afaacee-11a6-58b2-47df-5f79722c66ac\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "6afaacee-11a6-58b2-47df-5f79722c66ac" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_2daba8ca-211f-4f4b-4028-16c30fe22ee8\">See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)</a></p><p><b>status</b>: final</p><p><b>code</b>: Residual solvents <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOL)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 1.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Solvent <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SOLV)</span></td><td>Solvent 2 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8"
},
"status" : "final",
"code" : // ObservationDefinition/Solvents
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOL",
"display" : "Residual solvents"
}
]
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 1.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SOLV",
"display" : "Solvent"
}
]
},
"valueCodeableConcept" : {
"text" : "Solvent 2"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:c2644a86-1684-286e-00e2-dcaf907a8970",
"resource" : {
"resourceType" : "Observation",
"id" : "c2644a86-1684-286e-00e2-dcaf907a8970",
"text" : // observationWater
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"c2644a86-1684-286e-00e2-dcaf907a8970\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "c2644a86-1684-286e-00e2-dcaf907a8970" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_17b322fe-53ea-6c1f-521b-3b148ac05eb4\">See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.8 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:cb5f6872-6eeb-727a-7c33-f2c438581a1c",
"resource" : {
"resourceType" : "Observation",
"id" : "cb5f6872-6eeb-727a-7c33-f2c438581a1c",
"text" : // observationWater2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"cb5f6872-6eeb-727a-7c33-f2c438581a1c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "cb5f6872-6eeb-727a-7c33-f2c438581a1c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_17b322fe-53ea-6c1f-521b-3b148ac05eb4\">See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.8 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:7faaf980-7c10-7b9a-9572-1bacd485824e",
"resource" : {
"resourceType" : "Observation",
"id" : "7faaf980-7c10-7b9a-9572-1bacd485824e",
"text" : // observationWater3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"7faaf980-7c10-7b9a-9572-1bacd485824e\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "7faaf980-7c10-7b9a-9572-1bacd485824e" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_17b322fe-53ea-6c1f-521b-3b148ac05eb4\">See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Water Content <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.8 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4"
},
"status" : "final",
"code" : // ObservationDefinition/Water
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "WaterContent",
"display" : "Water Content"
}
],
"text" : "Water Content"
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.8,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
},
{
"fullUrl" : "urn:uuid:e4d2118a-8562-9eb1-2c14-4e145d2a95fc",
"resource" : {
"resourceType" : "Observation",
"id" : "e4d2118a-8562-9eb1-2c14-4e145d2a95fc",
"text" : // observationParticleSize-size1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"e4d2118a-8562-9eb1-2c14-4e145d2a95fc\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "e4d2118a-8562-9eb1-2c14-4e145d2a95fc" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>D(v,0.9) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.9)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:ec078717-9512-4db4-77c6-2c7e29d213a6",
"resource" : {
"resourceType" : "Observation",
"id" : "ec078717-9512-4db4-77c6-2c7e29d213a6",
"text" : // observationParticleSize-size1-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"ec078717-9512-4db4-77c6-2c7e29d213a6\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "ec078717-9512-4db4-77c6-2c7e29d213a6" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.4 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Impurity <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#IMP)</span></td><td>D(v,0.9) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "IMP",
"display" : "Impurity"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.9)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:05cfb495-2580-561a-688d-ce6ea24c8962",
"resource" : {
"resourceType" : "Observation",
"id" : "05cfb495-2580-561a-688d-ce6ea24c8962",
"text" : // observationParticleSize-size1-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"05cfb495-2580-561a-688d-ce6ea24c8962\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "05cfb495-2580-561a-688d-ce6ea24c8962" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.9) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.9)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:d2a60ae5-96b4-3d13-38da-729c652347a3",
"resource" : {
"resourceType" : "Observation",
"id" : "d2a60ae5-96b4-3d13-38da-729c652347a3",
"text" : // observationParticleSize-size2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"d2a60ae5-96b4-3d13-38da-729c652347a3\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "d2a60ae5-96b4-3d13-38da-729c652347a3" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.5 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.5) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.5,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.5)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:c3f51325-2f5f-194c-919b-2219ee1f5c45",
"resource" : {
"resourceType" : "Observation",
"id" : "c3f51325-2f5f-194c-919b-2219ee1f5c45",
"text" : // observationParticleSize-size2-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"c3f51325-2f5f-194c-919b-2219ee1f5c45\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "c3f51325-2f5f-194c-919b-2219ee1f5c45" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.4 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.5) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.4,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.5)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e9d89693-11b1-13ed-5cde-606fc1b8372c",
"resource" : {
"resourceType" : "Observation",
"id" : "e9d89693-11b1-13ed-5cde-606fc1b8372c",
"text" : // observationParticleSize-size2-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"e9d89693-11b1-13ed-5cde-606fc1b8372c\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "e9d89693-11b1-13ed-5cde-606fc1b8372c" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.2 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.5) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.2,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.5)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:2659b000-96e2-1b8b-129b-0c00e1074b0f",
"resource" : {
"resourceType" : "Observation",
"id" : "2659b000-96e2-1b8b-129b-0c00e1074b0f",
"text" : // observationParticleSize-size3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"2659b000-96e2-1b8b-129b-0c00e1074b0f\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "2659b000-96e2-1b8b-129b-0c00e1074b0f" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\">See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.1) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/substance-drug-pq-ex1
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.1)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:10b47328-36fa-343d-5699-5b32b30a6d33",
"resource" : {
"resourceType" : "Observation",
"id" : "10b47328-36fa-343d-5699-5b32b30a6d33",
"text" : // observationParticleSize-size3-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"10b47328-36fa-343d-5699-5b32b30a6d33\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "10b47328-36fa-343d-5699-5b32b30a6d33" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\">See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.1) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-2
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.1)"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e6780766-317a-382f-92d2-79825f506cc5",
"resource" : {
"resourceType" : "Observation",
"id" : "e6780766-317a-382f-92d2-79825f506cc5",
"text" : // observationParticleSize-size3-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Observation</b><a name=\"e6780766-317a-382f-92d2-79825f506cc5\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource Observation "e6780766-317a-382f-92d2-79825f506cc5" </p></div><p><b>instantiates</b>: <a href=\"#ObservationDefinition_11fcfe6b-7498-132b-2def-efae51b302d4\">See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)</a></p><p><b>status</b>: final</p><p><b>code</b>: Particle size distribution <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#PART)</span></p><p><b>subject</b>: <a href=\"#Substance_ef17cff1-6586-a4a4-9168-2602140548d7\">See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)</a></p><p><b>effective</b>: 2023-01-01 12:00:00+0000</p><p><b>performer</b>: <a href=\"#Organization_378fbe5f-5926-3a5c-4c64-5428df877b08\">See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)</a></p><p><b>value</b>: 0.1 % w/w<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code % = '%')</span></p><h3>Components</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Particle Size <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-local-codes-drug-pq.html\">CodeSystem - Example Local Codes - Drug</a>#SIZE)</span></td><td>D(v,0.1) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></td></tr></table></div>"
},
"instantiatesReference" : {
"reference" : "ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4"
},
"status" : "final",
"code" : // ObservationDefinition/Particles
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "PART",
"display" : "Particle size distribution"
}
]
},
"subject" : {
"reference" : "Substance/ef17cff1-6586-a4a4-9168-2602140548d7"
},
"effectiveDateTime" : "2023-01-01T12:00:00Z",
"performer" : [
// Substance/actual-batch-substance-3
{
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b08"
}
],
"valueQuantity" : // Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
{
"value" : 0.1,
"unit" : "% w/w",
"system" : "http://unitsofmeasure.org",
"code" : "%"
},
"component" : [
{
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq",
"code" : "SIZE",
"display" : "Particle Size"
}
]
},
"valueCodeableConcept" : {
"text" : "D(v,0.1)"
}
}
]
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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