Pharmaceutical Quality (Industry)
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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

Drug Specification: CMC synthetic data rendering - drug substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

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Bundle [documentation R4 R5 R6]
id: bundle-drug-substance-specification-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq
Type: collection
Plan [documentation R4 R5 R6]
id: specificationProtocol
fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
url (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
Title: SPECIFICATION FOR DRUG SUBSTANCE
Description: Narrative description of specifications
Status: active
Subject
Found a parent (PlanDefinition/subjectReference, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Name: AAA Molybdenum Products, Inc.
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA

Action: Specification for Drug Substance


Test ProcedureAcceptance Criteria Method Reference
Description A white to brown powder Visual inspection
Identification Conforms with reference Identification by IR spectroscopy Identification by HPLC
Assay 98 % w/w - 102 % w/w Assay by LC
Drug Substance Related Organic impurities
Impurity 1 NMT 0.5 % w/w Organic impurities by LC
Impurity 2 NMT 0.5 % w/w
Any individual unspecified impurity NMT 0.10 % w/w
Total impurities NMT 2.0 % w/w
Mutagenic impurities NMT 50 ppm Impurity 5 content by LC-MS
Enantiomeric purity NLT 99.6 % Enantiomeric purity by LC
Residual solvents
Solvent 1 NMT 0.1 % w/w Residual solvents by headspace GC
Solvent 2 NMT 2.0 % w/w
Water Content NMT 1.0 % w/w USP Karl Fischer titration
Particle size distribution
D(v,0.9) NMT 319 µm Laser diffraction
D(v,0.5) NMT 145 µm
D(v,0.1) NMT 20 µm

Action - Specification for Drug Substance - Overall set of actions
Title: Specification for Drug Substance
Code: Overall set of actions
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Description [documentation R4 R5 R6]
id: Description
fullUrl: urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9
url (canonical): http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
Title: Description
Status: active
Code: Description [DESC] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Description
Method: Visual inspection
Acceptable Value
Text: A white to brown powder
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Identification [documentation R4 R5 R6]
id: Identification
fullUrl: urn:uuid:b50d892c-8980-0774-39d4-d449732873a3
url (canonical): http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
Title: Identification
Status: active
Code: Identification [IDT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Identification
Method: Identification by IR spectroscopy Identification by HPLC
Acceptable Value
Text: Conforms with reference
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Assay [documentation R4 R5 R6]
id: Assay
fullUrl: urn:uuid:d460b561-110c-7eb6-5d69-788abcca391a
url (canonical): http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
Title: Assay
Status: active
Code: Assay [ASSAY] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Assay
Method: Assay by LC
Acceptable Value
Range: from 98% w/w [%] (http://unitsofmeasure.org) to 102% w/w [%] (http://unitsofmeasure.org)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Drug Substance Related Organic impurities [DGP-s] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) [documentation R4 R5 R6]
id: Impurities
fullUrl: urn:uuid:006a9f7b-91ca-5601-38ef-a3dd26ad7121
url (canonical): http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
Title: Drug Substance Related Organic impurities
Status: active
Code: Drug Substance Related Organic impurities [DGP-s] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Method: Organic impurities by LC
Acceptable Value
Applies To: Impurity 1
Range: to 0.5% w/w
Acceptable Value
Applies To: Impurity 2
Range: to 0.5% w/w
Acceptable Value
Applies To: Any individual unspecified impurity
Range: to 0.10% w/w
Acceptable Value
Applies To: Total impurities
Range: to 2.0% w/w
Component - Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Mutagenic impurities [MUT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) [documentation R4 R5 R6]
id: Mutagenic
fullUrl: urn:uuid:c59deb1b-835c-1be5-4e08-95dea3ae1a17
url (canonical): http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
Title: Mutagenic impurities
Status: active
Code: Mutagenic impurities [MUT] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Method: Impurity 5 content by LC-MS
Acceptable Value
Applies To: Impurity - Mutagenic
Range: to 50 ppm [[ppm]] (http://unitsofmeasure.org)
Component - Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: Impurity [IMP] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Enantiomeric purity [enantiomeric-purity] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Enantiomeric purity [documentation R4 R5 R6]
id: Enantiomeric
fullUrl: urn:uuid:18e20bae-1a24-202d-11d7-5f354c785e4d
url (canonical): http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
Title: Enantiomeric purity
Status: active
Code: Enantiomeric purity [enantiomeric-purity] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Enantiomeric purity
Method: Enantiomeric purity by LC
Acceptable Value
Range: from 99.6% [%] (http://unitsofmeasure.org)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Residual solvents [SOL] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) [documentation R4 R5 R6]
id: Solvents
fullUrl: urn:uuid:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
url (canonical): http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
Title: Residual solvents
Status: active
Code: Residual solvents [SOL] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Method: Residual solvents by headspace GC
Acceptable Value
Applies To: Solvent 1
Range: to 0.1% w/w
Acceptable Value
Applies To: Solvent 2
Range: to 2.0% w/w
Component - Solvent [SOLV] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: Solvent [SOLV] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Water Content [documentation R4 R5 R6]
id: Water
fullUrl: urn:uuid:b4f736ff-1bbf-6923-4d5c-85d262285d7d
url (canonical): http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
Title: Water Content
Status: active
Code: Water Content [WaterContent] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) - Text: Water Content
Method: USP Karl Fischer titration
Acceptable Value
Range: to 1.0% w/w
Action - Test
Code: Test
Found a parent (PlanDefinition/action, id: specificationProtocol fullUrl: urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265aurl (canonical): http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a)
which is linked to this by resource.id
Observation Definition - Particle size distribution [particle-size-distribution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq) [documentation R4 R5 R6]
id: Particles
fullUrl: urn:uuid:233865df-2a71-528d-756c-85f36bd6685f
url (canonical): http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f
Title: Particle size distribution
Status: active
Code: Particle size distribution [particle-size-distribution] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Method: Laser diffraction
Acceptable Value
Applies To: D(v,0.9)
Range: to 319 µm [um] (http://unitsofmeasure.org)
Acceptable Value
Applies To: D(v,0.5)
Range: to 145 µm [um] (http://unitsofmeasure.org)
Acceptable Value
Applies To: D(v,0.1)
Range: to 20 µm [um] (http://unitsofmeasure.org)
Component - Particle size [particle-size] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)
Code: Particle size [particle-size] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq)