Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Example Bundle: Example: Bundle - Impurities, product

Bundle bundle-product-impurities-pq-ex1 of type collection


Entry 1 - fullUrl = urn:uuid:6f4a3311-92c5-2b4a-533e-76341e414c63

Resource DiagnosticReport:

Impurities Report

When For2020-12
Identifier: https://eudract.europa.eu/example/identifier/ABC1234

Report Details

CodeValueWhen For
Degradation Products<5 ppm2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation Products<5 ppm2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation Products<50 ppm2023-01-01 12:00:00+0000
Degradation Products<50 ppm2023-01-01 12:00:00+0000
Degradation Products<50 ppm2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation Products<10 ppm2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation ProductsND2023-01-01 12:00:00+0000
Degradation Products250 ppm2023-01-01 12:00:00+0000
Degradation Products223 ppm2023-01-01 12:00:00+0000
Degradation Products199 ppm2023-01-01 12:00:00+0000
  1. 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

-ExtensionLotNumber
*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

-ExtensionLotNumber
*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

-ExtensionLotNumber
*33447


Entry 5 - fullUrl = urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a

Resource Organization:

Generated Narrative: Organization

Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a"

identifier: urn:oid:2.16.840.1.113883.4.82/3010027650

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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-CodeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-TypeValue[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

-Reference
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a3)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a4)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a5)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a6)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a7)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a0)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a8)
*See above (SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a9)

name

productName: Stelbat Tablets, 20mg

type: Proprietary (CodeSystem - Product Name Type#Proprietary)

Parts

-PartType
*20mgStrength 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: urn:oid:2.16.840.1.113883.4.82/3007270600

name: Advanced Analytical Testing Laboratories Inc.

Contacts

-Address
*30 Silverline Drive North Brunswick New Jersey 08902 USA