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
Bundle bundle-product-impurities-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:6f4a3311-92c5-2b4a-533e-76341e414c63
Resource DiagnosticReport:
Impurities Report
When For 2020-12 Identifier: id: ABC1234 Report Details
Code Value When For Degradation Products <5 ppm 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products <5 ppm 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products <50 ppm 2023-01-01 12:00:00+0000 Degradation Products <50 ppm 2023-01-01 12:00:00+0000 Degradation Products <50 ppm 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products <10 ppm 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products ND 2023-01-01 12:00:00+0000 Degradation Products 250 ppm 2023-01-01 12:00:00+0000 Degradation Products 223 ppm 2023-01-01 12:00:00+0000 Degradation Products 199 ppm 2023-01-01 12:00:00+0000
- Elemental Impurities - No elemental impurities are intentionally added during the manufacturing of drug product...
Entry 2 - fullUrl = urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51
Resource Medication:
Generated Narrative: Medication
Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"
code: ()
Batches
Extension LotNumber 33445
Entry 3 - fullUrl = urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc
Resource Medication:
Generated Narrative: Medication
Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc"
code: ()
Batches
Extension LotNumber 33446
Entry 4 - fullUrl = urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06
Resource Medication:
Generated Narrative: Medication
Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06"
code: ()
Batches
Extension LotNumber 33447
Entry 5 - fullUrl = urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a
Resource Organization:
Generated Narrative: Organization
Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a"
identifier: id: 3010027650
name: AAA Pharmaceutical, Inc.
Contacts
Address 681 Main Street Lumberton New Jersey 08048 USA
Entry 6 - fullUrl = urn:uuid:ab7997fa-7b46-1175-3f01-6f6997f7878a
Resource Observation:
Generated Narrative: Observation
Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <5 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Entry 7 - fullUrl = urn:uuid:4052f28b-64a2-392d-35e4-ec8e912434d2
Resource Observation:
Generated Narrative: Observation
Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Entry 8 - fullUrl = urn:uuid:34ebc51d-8105-0589-3c8d-e7aa6bd0a06c
Resource Observation:
Generated Narrative: Observation
Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Entry 9 - fullUrl = urn:uuid:2940bf11-05bf-6ce2-3c64-457d0d1f9913
Resource Observation:
Generated Narrative: Observation
Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Entry 10 - fullUrl = urn:uuid:332b1e76-6f70-2b4e-5d0c-f22a0e042d3e
Resource Observation:
Generated Narrative: Observation
Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Entry 11 - fullUrl = urn:uuid:f0a13a3b-2e8b-594f-6874-6050511e4c57
Resource Observation:
Generated Narrative: Observation
Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Entry 12 - fullUrl = urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a795
Resource Observation:
Generated Narrative: Observation
Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Entry 13 - fullUrl = urn:uuid:be016630-8754-7414-9014-21e020ad66c6
Resource Observation:
Generated Narrative: Observation
Resource Observation "be016630-8754-7414-9014-21e020ad66c6"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Entry 14 - fullUrl = urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd6
Resource Observation:
Generated Narrative: Observation
Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <5 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Entry 15 - fullUrl = urn:uuid:7fe7ccd7-6449-0186-2282-3eeb4cf6a796
Resource Observation:
Generated Narrative: Observation
Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a796"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Entry 16 - fullUrl = urn:uuid:be016630-8754-7414-9014-21e020ad66c7
Resource Observation:
Generated Narrative: Observation
Resource Observation "be016630-8754-7414-9014-21e020ad66c7"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Entry 17 - fullUrl = urn:uuid:92568f68-78f3-908c-6935-ff5f3d574dd7
Resource Observation:
Generated Narrative: Observation
Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd7"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Entry 18 - fullUrl = urn:uuid:a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12
Resource Observation:
Generated Narrative: Observation
Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <50 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Entry 19 - fullUrl = urn:uuid:d8533dcb-03f8-5997-6ccf-4f9b6f7a5745
Resource Observation:
Generated Narrative: Observation
Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <50 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Entry 20 - fullUrl = urn:uuid:7cec19a2-34a7-6b80-3d60-083b2cc64fcb
Resource Observation:
Generated Narrative: Observation
Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <50 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Entry 21 - fullUrl = urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e7
Resource Observation:
Generated Narrative: Observation
Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Entry 22 - fullUrl = urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1899
Resource Observation:
Generated Narrative: Observation
Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Entry 23 - fullUrl = urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c78
Resource Observation:
Generated Narrative: Observation
Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: <10 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Entry 24 - fullUrl = urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e8
Resource Observation:
Generated Narrative: Observation
Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e8"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Entry 25 - fullUrl = urn:uuid:6a78bcde-4781-226c-946e-a4b6915c1890
Resource Observation:
Generated Narrative: Observation
Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1890"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Entry 26 - fullUrl = urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c79
Resource Observation:
Generated Narrative: Observation
Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c79"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: ND
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Entry 27 - fullUrl = urn:uuid:27aa47fd-7964-4f96-6495-b2bec7f160e9
Resource Observation:
Generated Narrative: Observation
Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e9"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: 250 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Entry 28 - fullUrl = urn:uuid:6a78bcde-4781-226c-946e-a4b6915c189b
Resource Observation:
Generated Narrative: Observation
Resource Observation "6a78bcde-4781-226c-946e-a4b6915c189b"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: 223 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Entry 29 - fullUrl = urn:uuid:f9f11088-7527-947c-3d3f-e71b32e13c70
Resource Observation:
Generated Narrative: Observation
Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c70"
status: FINAL
code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)
subject: See above (Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9)
value: 199 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (CodeSystem - Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Entry 30 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a3
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a3"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 1 () Codes
Code Cadmium (substance) (SNOMED CT#66586000)
Entry 31 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a4
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a4"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 1 () Codes
Code Lead (substance) (SNOMED CT#88488004)
Entry 32 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a5
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a5"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 1 () Codes
Code Arsenic (substance) (SNOMED CT#47809000)
Entry 33 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a6
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a6"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 1 () Codes
Code Mercury (substance) (SNOMED CT#45262002)
Entry 34 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a7
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a7"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 2 () Codes
Code Cobalt (substance) (SNOMED CT#54808007)
Entry 35 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a8
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a8"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 2 () Codes
Code Vanadium (substance) (SNOMED CT#18925001)
Entry 36 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a9
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a9"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 2 () Codes
Code Nickel (substance) (SNOMED CT#33396006)
Entry 37 - fullUrl = urn:uuid:fec78d02-1ec2-48ac-bab3-5ed8b6adf9a0
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a0"
Properties
Type Value[x] Impurity Classification - Mutagenic and Carcinogenic Potential (CodeSystem - Substance Property Type#impurityClassificationMCP) Class 3 () Codes
Code Copper (substance) (SNOMED CT#66925006)
Entry 38 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Textual description of the product
combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)
route: Oral use (standardterms.edqm.eu#20053000)
Impurities
name
productName: Stelbat Tablets, 20mg
type: Proprietary (CodeSystem - Product Name Type#Proprietary)
Parts
Part Type 20mg Strength part (Product Name Part Type#StrengthPart)
Entry 39 - fullUrl = urn:uuid:e3d2bc19-2f10-2b4d-1741-e4135fe612a9
Resource Organization:
Generated Narrative: Organization
Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9"
identifier: id: 3007270600
name: Advanced Analytical Testing Laboratories Inc.
Contacts
Address 30 Silverline Drive North Brunswick New Jersey 08902 USA
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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