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 – Stability, substance

Bundle bundle-drug-stability-pq-ex2-sub of type collection


Entry 1 - fullUrl = urn:uuid:54c8e8dc-9a19-0dc2-910e-d5a05d6ba003

Resource DiagnosticReport:

Stability Study Report

When For2019-09-08
Identifier: https://eudract.europa.eu/example/identifier/PLO555

Report Details

CodeValueWhen For
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Test Components - Long-term 25C etc - Initial (XYZ)2023-01-01 12:00:00+0000
Long-term - 30°C/65% RH - 18 months (X)2023-01-01 12:00:00+0000
Long-term - 30°C/65% RH - 18 months (X)2023-01-01 12:00:00+0000
Long-term - 30°C/65% RH - 18 months (X)2023-01-01 12:00:00+0000
Accelerated - 40°C/67% RH - 3 months (X)2023-01-01 12:00:00+0000

The samples have been assessed and the conclusion is...


Entry 2 - fullUrl = urn:uuid:c3973835-10ca-0796-0a26-aa8afafc9c5b

Resource PlanDefinition:

Generated Narrative: PlanDefinition

Resource PlanDefinition "c3973835-10ca-0796-0a26-aa8afafc9c5b"

url: http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b

title: Stability Monitoring Program

type: Stability Study Protocol (planType#1244588)

status: ACTIVE

subject: See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)

description: Description of the study study plan which includes tests, time points, storage conditions, method

action

title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol

action

action


Entry 3 - fullUrl = urn:uuid:643d8b44-71f4-2b58-07e8-51c22b294b25

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition

Resource SpecimenDefinition "643d8b44-71f4-2b58-07e8-51c22b294b25"

url: http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25

status: ACTIVE

typeTested

preference: PREFERRED

Handlings

-Instruction
*30°C/65% RH


Entry 4 - fullUrl = urn:uuid:10d7b693-7a0e-2f71-9a10-642e5a0a5d42

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "10d7b693-7a0e-2f71-9a10-642e5a0a5d42"

url: http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42

title: Long-term - 30°C/65% RH - XY

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba, http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e


Entry 5 - fullUrl = urn:uuid:480a61f8-14b3-233e-8e5f-7f0db9696a1e

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "480a61f8-14b3-233e-8e5f-7f0db9696a1e"

url: http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 6 - fullUrl = urn:uuid:bee486c4-6ab5-6293-4114-d4be24f303d3

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "bee486c4-6ab5-6293-4114-d4be24f303d3"

url: http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 7 - fullUrl = urn:uuid:99893d3c-520c-8d7b-6d73-f46b1a662201

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "99893d3c-520c-8d7b-6d73-f46b1a662201"

url: http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 8 - fullUrl = urn:uuid:b3254b8e-6fc3-88d3-7d38-0afcf13c4f67

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67"

url: http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 9 - fullUrl = urn:uuid:c9b53a46-2f61-7b3f-5780-5f5c79a47f12

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "c9b53a46-2f61-7b3f-5780-5f5c79a47f12"

url: http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 10 - fullUrl = urn:uuid:d6f7de9d-57a5-6a2c-1c2f-0d65718860f2

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2"

url: http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 11 - fullUrl = urn:uuid:75073965-82eb-407d-34cf-3a7767a38149

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "75073965-82eb-407d-34cf-3a7767a38149"

url: http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149

title: Long-term - 30°C/65% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba


Entry 12 - fullUrl = urn:uuid:18762cff-9e29-6e71-1184-e9202fee8cba

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "18762cff-9e29-6e71-1184-e9202fee8cba"

url: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba

title: X

status: ACTIVE

code: Battery of tests 'X' at 30°C/65% RH ()

specimen: See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)

hasMember:


Entry 13 - fullUrl = urn:uuid:559ffdc3-349b-a4a3-a651-ce2715f08d69

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "559ffdc3-349b-a4a3-a651-ce2715f08d69"

url: http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

title: Description

status: ACTIVE

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

QualifiedValues

-Extension
*


Entry 14 - fullUrl = urn:uuid:7943795a-2abe-666f-545f-133e23b97119

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "7943795a-2abe-666f-545f-133e23b97119"

url: http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

title: Assay (% w/w) (Mean)

status: ACTIVE

code: Assay (% w/w) (Mean) (CodeSystem - Example Local Codes - Drug#ASSAY "Assay")

QualifiedValues

-Range
*98-102 % w/w


Entry 15 - fullUrl = urn:uuid:73d9d304-a0b8-31b6-1165-346563b9305e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e"

url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

title: Drug-related Impurities Content by LC (% w/w)

status: ACTIVE

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

qualifiedValue

appliesTo: Impurity ()

range: ?-0.5

qualifiedValue

appliesTo: Impurity 2 ()

range: ?-0.52

qualifiedValue

appliesTo: Any Unspecified Impurity ()

range: ?-0.10

qualifiedValue

appliesTo: Total Impurities ()

range: ?-2.0

Components

-Code
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)


Entry 16 - fullUrl = urn:uuid:31abea79-81da-17f8-9d8c-94e9bb75876e

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "31abea79-81da-17f8-9d8c-94e9bb75876e"

url: http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e

title: Y

status: ACTIVE

code: Battery of tests 'Y' at 30°C/65% RH ()

specimen: See above (SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25)

hasMember: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)


Entry 17 - fullUrl = urn:uuid:6b96124b-1a44-0b6b-6783-d6c49360230b

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b"

url: http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

title: Identification

status: ACTIVE

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

QualifiedValues

-Extension
*


Entry 18 - fullUrl = urn:uuid:306637ec-1041-80e8-8e77-e7ca814253e1

Resource SpecimenDefinition:

Generated Narrative: SpecimenDefinition

Resource SpecimenDefinition "306637ec-1041-80e8-8e77-e7ca814253e1"

url: http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1

status: ACTIVE

typeTested

preference: PREFERRED

Handlings

-Instruction
*40°C/75% RH


Entry 19 - fullUrl = urn:uuid:1b43a536-3c29-3427-0b93-e35866ef8495

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "1b43a536-3c29-3427-0b93-e35866ef8495"

url: http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495

title: Accelerated - 40°C/70% RH - XY

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc, http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6


Entry 20 - fullUrl = urn:uuid:8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9"

url: http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9

title: Accelerated - 40°C/70% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc


Entry 21 - fullUrl = urn:uuid:cf2f00df-971f-0bab-8768-4251b1ad0817

Resource ActivityDefinition:

Generated Narrative: ActivityDefinition

Resource ActivityDefinition "cf2f00df-971f-0bab-8768-4251b1ad0817"

url: http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817

title: Accelerated - 40°C/70% RH - X

status: ACTIVE

observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc


Entry 22 - fullUrl = urn:uuid:35fa7b97-98d3-35d3-5672-4ab1047d57fc

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "35fa7b97-98d3-35d3-5672-4ab1047d57fc"

url: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc

title: X

status: ACTIVE

code: Battery of tests 'X' at 40°C/75% RH ()

specimen: See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)

hasMember:


Entry 23 - fullUrl = urn:uuid:accb8802-4223-61e2-8c79-2282e22a2bb6

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition

Resource ObservationDefinition "accb8802-4223-61e2-8c79-2282e22a2bb6"

url: http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6

title: Y

status: ACTIVE

code: Battery of tests 'Y' at 40°C/75% RH ()

specimen: See above (SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1)

hasMember: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)


Entry 24 - fullUrl = urn:uuid:6a5354bf-602c-99f1-324b-0bb5f7e06cd5

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "6a5354bf-602c-99f1-324b-0bb5f7e06cd5"

Collections

-Collected[x]
*2020-06

processing

description: No storage

processing

description: 25°C/60% RH


Entry 25 - fullUrl = urn:uuid:588a6787-0454-55ef-0b8a-4c8941b6976c

Resource Observation:

Generated Narrative: Observation

Resource Observation "588a6787-0454-55ef-0b8a-4c8941b6976c"

Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)

status: FINAL

code: Test Components - Long-term 25C etc - Initial (XYZ) ()

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.15 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.05 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.8 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()


Generated Narrative: Observation #LongTerm30C-initial-1-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-initial-1-Impurity1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.1 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.2 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.05 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.8 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-initial-1-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.15 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-initial-1-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Entry 26 - fullUrl = urn:uuid:3b550915-4467-83d3-340f-9bd6d2857191

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "3b550915-4467-83d3-340f-9bd6d2857191"

Collections

-Collected[x]
*2020-06

processing

description: No storage

processing

description: 25°C/60% RH


Entry 27 - fullUrl = urn:uuid:930c7f69-2546-7148-2069-b3be3a755edf

Resource Observation:

Generated Narrative: Observation

Resource Observation "930c7f69-2546-7148-2069-b3be3a755edf"

Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)

status: FINAL

code: Test Components - Long-term 25C etc - Initial (XYZ) ()

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/3b550915-4467-83d3-340f-9bd6d2857191)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.152 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.12 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.22 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.052 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.82 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Does not comply ()


Generated Narrative: Observation #LongTerm30C-initial-2-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.12 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.22 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.052 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.82 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-initial-2-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.152 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-initial-2-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Does not comply ()


Entry 28 - fullUrl = urn:uuid:b1726ce3-8bb5-403e-2e9b-f5d79cc716f9

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9"

Collections

-Collected[x]
*2020-06

processing

description: No storage

processing

description: 25°C/60% RH


Entry 29 - fullUrl = urn:uuid:8070745c-30c4-a52e-41fd-600a913578d4

Resource Observation:

Generated Narrative: Observation

Resource Observation "8070745c-30c4-a52e-41fd-600a913578d4"

Triggered by: See above (ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42)

status: FINAL

code: Test Components - Long-term 25C etc - Initial (XYZ) ()

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.152 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.12 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.22 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.052 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.82 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Does not comply ()


Generated Narrative: Observation #LongTerm30C-initial-3-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.12 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.22 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.052 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.82 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-initial-3-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.152 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-initial-3-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Does not comply ()


Entry 30 - fullUrl = urn:uuid:7aa5fdea-17d7-29f1-1ed4-5c05eb62285a

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a"

Collections

-Collected[x]
*2020-06

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 30°C/65% RH


Entry 31 - fullUrl = urn:uuid:872a645f-120e-44c0-62c0-9be05acf543b

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "872a645f-120e-44c0-62c0-9be05acf543b"

Collections

-Collected[x]
*2020-06

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 30°C/65% RH


Entry 32 - fullUrl = urn:uuid:7c06a03c-9cf7-2e1b-a236-d60038f1439b

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "7c06a03c-9cf7-2e1b-a236-d60038f1439b"

Collections

-Collected[x]
*2020-06

processing

description: Store for 18 months

time: 2020-12 --> 2022-06

processing

description: 30°C/65% RH


Entry 33 - fullUrl = urn:uuid:f16113fe-27e7-0aa2-6787-9415f5051900

Resource Observation:

Generated Narrative: Observation

Resource Observation "f16113fe-27e7-0aa2-6787-9415f5051900"

Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)

status: FINAL

code: Long-term - 30°C/65% RH - 18 months (X) ()

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-1-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-1-Impurity1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-18m-1-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-18m-1-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Entry 34 - fullUrl = urn:uuid:1b25eb25-9149-02f6-9676-c87f90c64904

Resource Observation:

Generated Narrative: Observation

Resource Observation "1b25eb25-9149-02f6-9676-c87f90c64904"

Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)

status: FINAL

code: Long-term - 30°C/65% RH - 18 months (X) ()

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/872a645f-120e-44c0-62c0-9be05acf543b)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/cbcecab6-374c-396f-29be-877da7285e8d)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-2-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-2-Impurity1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-18m-2-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-18m-2-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Entry 35 - fullUrl = urn:uuid:004ed877-7729-834e-3b6b-a2cf4bdb2377

Resource Observation:

Generated Narrative: Observation

Resource Observation "004ed877-7729-834e-3b6b-a2cf4bdb2377"

Triggered by: See above (ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12)

status: FINAL

code: Long-term - 30°C/65% RH - 18 months (X) ()

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-3-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Generated Narrative: Observation #LongTerm30C-18m-3-Impurity1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.218 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.0518 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.818 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #LongTerm30C-18m-3-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.118 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #LongTerm30C-18m-3-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Entry 36 - fullUrl = urn:uuid:b04c9321-069c-4da8-8ed0-86337ea22c30

Resource Specimen:

Generated Narrative: Specimen

Resource Specimen "b04c9321-069c-4da8-8ed0-86337ea22c30"

Collections

-Collected[x]
*2020-06

processing

description: No storage

processing

description: 40°C/75% RH


Entry 37 - fullUrl = urn:uuid:f958e1e9-6023-4e39-2ffe-a9c8f135a2dd

Resource Observation:

Generated Narrative: Observation

Resource Observation "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd"

Triggered by: See above (ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9)

status: FINAL

code: Accelerated - 40°C/67% RH - 3 months (X) ()

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

specimen: See above (Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30)

hasMember:

instantiates: See above (ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69)

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Doesn't comply ()

instantiates: See above (ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119)

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.113 % w/w (Details: UCUM code % = '%')

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.113 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.213 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: <0.0513 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

instantiates: See above (ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e)

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: 0.813 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

instantiates: See above (ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b)

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: See above (Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd)

effective: 2023-01-01 12:00:00+0000

performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)

value: Complies ()


Generated Narrative: Observation #Accelerated40C-3m-1-Description

instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69

status: FINAL

code: Description (CodeSystem - Example Local Codes - Drug#DESC)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Doesn't comply ()


Generated Narrative: Observation #Accelerated40C-3m-1-Impurity1

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Degradation Products (CodeSystem - Example Local Codes - Drug#DGP)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.113 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity ()

Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.213 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Impurity 2 ()

Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityUnspecified

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: <0.0513 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Any Unspecified Impurity ()

Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityTotal

instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e

status: FINAL

code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.813 % w/w (Details: UCUM code % = '%')

Components

-CodeValue[x]
*Impurity (CodeSystem - Example Local Codes - Drug#IMP)Total Impurities ()

Generated Narrative: Observation #Accelerated40C-3m-1-Assay

instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119

status: FINAL

code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: 0.113 % w/w (Details: UCUM code % = '%')


Generated Narrative: Observation #Accelerated40C-3m-1-Identification

instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b

status: FINAL

code: Identification (CodeSystem - Example Local Codes - Drug#IDT)

subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd

effective: 2023-01-01 12:00:00+0000

performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08

value: Complies ()


Entry 38 - fullUrl = urn:uuid:62c1b1b4-8d15-26d2-57f9-25a2f60b6181

Resource Organization:

Generated Narrative: Organization

Resource Organization "62c1b1b4-8d15-26d2-57f9-25a2f60b6181"

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

-Address
*7233 W 116th Pl Ste C Broomfield Colorado 80020 USA


Entry 39 - fullUrl = urn:uuid:6049d921-9935-90b7-4efc-894a66483c00

Resource Organization:

Generated Narrative: Organization

Resource Organization "6049d921-9935-90b7-4efc-894a66483c00"

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


Entry 40 - fullUrl = urn:uuid:2e3a85b5-790a-a108-3627-edf0ec6f1210

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "2e3a85b5-790a-a108-3627-edf0ec6f1210"

identifier: http://example.company.org/companySubstanceIdentifier/4444455555

manufacturer: See above (Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181)

Names

-Name
*Stelbatolol


Entry 41 - fullUrl = urn:uuid:e2359a4e-3091-23f8-2242-87e701830d55

Resource Organization:

Generated Narrative: Organization

Resource Organization "e2359a4e-3091-23f8-2242-87e701830d55"

identifier: urn:oid:2.16.840.1.113883.4.82/3003040516

name: AAA Molybdenum Products, Inc.

Contacts

-Address
*7233 W 116th Pl Ste C Broomfield Colorado 80020 USA


Entry 42 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

Generated Narrative: Organization

Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"

name: Testing Lab


Entry 43 - fullUrl = urn:uuid:a3fdc23b-6c16-2e65-481e-3fc895b37b87

Resource Substance:

Generated Narrative: Substance

Resource Substance "a3fdc23b-6c16-2e65-481e-3fc895b37b87"

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-01

url

batchQuantity

value: 120 kg

url

batchUtilization

value: Production (NCI Thesaurus#C133990 "Commercial")

url

assignedManufacturer

value: See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)

url

container

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT1

instance: true

Codes

-Reference
*See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)


Entry 44 - fullUrl = urn:uuid:cbcecab6-374c-396f-29be-877da7285e8d

Resource Substance:

Generated Narrative: Substance

Resource Substance "cbcecab6-374c-396f-29be-877da7285e8d"

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-02

url

batchQuantity

value: 120 kg

url

batchUtilization

value: Production (NCI Thesaurus#C133990 "Commercial")

url

assignedManufacturer

value: See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT2

instance: true

Codes

-Reference
*See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)


Entry 45 - fullUrl = urn:uuid:ae1f3b4c-4f14-1460-6903-7260959ea2cd

Resource Substance:

Generated Narrative: Substance

Resource Substance "ae1f3b4c-4f14-1460-6903-7260959ea2cd"

Medication Manufacturing Batch

url

manufacturingDate

value: 2020-03

url

batchQuantity

value: 120 kg

url

batchUtilization

value: Production (NCI Thesaurus#C133990 "Commercial")

url

assignedManufacturer

value: See above (Organization/e2359a4e-3091-23f8-2242-87e701830d55)

Extension - Batch Release Date PQ: 2019-09-08

Extension - Batch Retest Date PQ: 2022-09-08

Extension - Actual Yield PQ: 4.8 kg

identifier: CAT3

instance: true

Codes

-Reference
*See above (SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210)