Example: Bundle – Batch Analysis, substance - Pharmaceutical Quality (Industry) v1.0.0-ballot

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

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

Example Bundle: Example: Bundle – Batch Analysis, substance

Bundle bundle-batch-analysis-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:2038e4c7-22b8-4c56-2d28-6c077648763f

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f"
Profile: PlanDefinition - Drug PQ
url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f
title: S.4.4 BATCH ANALYSIS
type: Specification Protocol (planType#1244577)
status: ACTIVE
subject: See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)
description: Narrative description of analysis
action
title: Batch Specification for Drug Substance
code: Overall set of actions ()
Actions
- Code Definition[x]
* Test () ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
* Test () ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
* Test () ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
* Test () ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
* Test () ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
* Test () ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
* Test () ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
* Test () ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
* Test () ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4

Entry 2 - fullUrl = urn:uuid:13033a89-927a-10e0-503e-5f901bdca30f

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "13033a89-927a-10e0-503e-5f901bdca30f"
url: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
title: Description
status: ACTIVE
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
method: Visual inspection ()
QualifiedValues
- Extension
*

Entry 3 - fullUrl = urn:uuid:8395ae1d-5064-0ab7-a297-6b20285b2230

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "8395ae1d-5064-0ab7-a297-6b20285b2230"
url: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
title: Identification
status: ACTIVE
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
method: Identification by IR spectroscopy Identification by HPLC ()
QualifiedValues
- Extension
*

Entry 4 - fullUrl = urn:uuid:2117208e-4185-9091-1f86-cce37b121838

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "2117208e-4185-9091-1f86-cce37b121838"
url: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
title: Assay
status: ACTIVE
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
method: Assay by LC ()
QualifiedValues
- Range
* 98-102 % w/w

Entry 5 - fullUrl = urn:uuid:d04e0f2a-6ee7-6c2e-1db8-7df394c927b8

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8"
url: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
title: Drug Substance Related Organic impurities
status: ACTIVE
code: Drug Substance Related Organic impurities (CodeSystem - Example Local Codes - Drug#DGP-s)
method: Organic impurities by LC ()
qualifiedValue
appliesTo: Impurity 1 ()
range: ?-0.5
qualifiedValue
appliesTo: Impurity 2 ()
range: ?-0.5
qualifiedValue
appliesTo: Impurity 3 ()
range: ?-0.5
qualifiedValue
appliesTo: Any individual unspecified impurity ()
range: ?-0.10
qualifiedValue
appliesTo: Total impurities ()
range: ?-2.0
Components
- Code
* Impurity (CodeSystem - Example Local Codes - Drug#IMP)

Entry 6 - fullUrl = urn:uuid:0634020c-8729-99fc-7637-89799d7c445b

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "0634020c-8729-99fc-7637-89799d7c445b"
url: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
title: Mutagenic impurities
status: ACTIVE
code: Mutagenic impurities (CodeSystem - Example Local Codes - Drug#MUT)
method: Impurity 5 content by LC-MS ()
QualifiedValues
- AppliesTo Range
* Impurity - Mutagenic () ?-50
Components
- Code
* Impurity (CodeSystem - Example Local Codes - Drug#IMP)

Entry 7 - fullUrl = urn:uuid:4e67725b-20c8-158e-9d53-1810bfa58d87

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "4e67725b-20c8-158e-9d53-1810bfa58d87"
url: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
title: Enantiomeric purity
status: ACTIVE
code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)
method: Enantiomeric purity by LC ()
QualifiedValues
- Range
* 99.6-? %

Entry 8 - fullUrl = urn:uuid:2daba8ca-211f-4f4b-4028-16c30fe22ee8

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "2daba8ca-211f-4f4b-4028-16c30fe22ee8"
url: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
title: Residual solvents
status: ACTIVE
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
method: Residual solvents by headspace GC ()
qualifiedValue
appliesTo: Solvent 1 ()
range: ?-0.1
qualifiedValue
appliesTo: Solvent 2 ()
range: ?-2.0
Components
- Code
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV)

Entry 9 - fullUrl = urn:uuid:17b322fe-53ea-6c1f-521b-3b148ac05eb4

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "17b322fe-53ea-6c1f-521b-3b148ac05eb4"
url: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
title: Water Content
status: ACTIVE
code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)
method: USP Karl Fischer titration ()
QualifiedValues
- Range
* ?-1.0

Entry 10 - fullUrl = urn:uuid:11fcfe6b-7498-132b-2def-efae51b302d4

Resource ObservationDefinition:

Generated Narrative: ObservationDefinition
Resource ObservationDefinition "11fcfe6b-7498-132b-2def-efae51b302d4"
url: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
title: Particle size distribution
status: ACTIVE
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
method: Laser diffraction ()
qualifiedValue
appliesTo: D(v,0.9) ()
range: ?-319
qualifiedValue
appliesTo: D(v,0.5) ()
range: ?-145
qualifiedValue
appliesTo: D(v,0.1) ()
range: ?-20
Components
- Code
* Particle size (CodeSystem - Example Local Codes - Drug#PARTS)

Entry 11 - fullUrl = urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1

Resource Substance:

Generated Narrative: Substance
Resource Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1"
Medication Manufacturing Batch
url
batchQuantity
value: 120 kg
url
manufacturingDate
value: 2020-01
url
batchUtilization
value: Production (NCI Thesaurus#C133990 "Commercial")
url
assignedManufacturer
value: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Manufacturing Process PQ: See above (PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975)
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT1
instance: true
Codes
- Reference
* See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)

Entry 12 - fullUrl = urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4

Resource Substance:

Generated Narrative: Substance
Resource Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4"
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/3d399cbc-244e-9b5f-838b-b7daa0489330)
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT2
instance: true
Codes
- Reference
* See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)

Entry 13 - fullUrl = urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7

Resource Substance:

Generated Narrative: Substance
Resource Substance "ef17cff1-6586-a4a4-9168-2602140548d7"
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/3d399cbc-244e-9b5f-838b-b7daa0489330)
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: id: CAT3
instance: true
Codes
- Reference
* See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)

Entry 14 - fullUrl = urn:uuid:b30a1024-37db-a1bc-05e5-cc4596d92975

Resource PlanDefinition:

Generated Narrative: PlanDefinition
Resource PlanDefinition "b30a1024-37db-a1bc-05e5-cc4596d92975"
url: http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975
title: Process 1.1
type: Manufacturing Process (planType#1244566)
status: ACTIVE
subject: See above (SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130)

Entry 15 - fullUrl = urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "8dae93e0-048d-35a4-71ea-7c603184a130"
manufacturer: See above (Organization/3d399cbc-244e-9b5f-838b-b7daa0489330)
Names
- Name
* Stelbatolol

Entry 16 - fullUrl = urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330

Resource Organization:

Generated Narrative: Organization
Resource Organization "3d399cbc-244e-9b5f-838b-b7daa0489330"
identifier: id: 3003040516
name: AAA Molybdenum Products, Inc.
Contacts
- Address
* 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 17 - fullUrl = urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b08

Resource Organization:

Generated Narrative: Organization
Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08"
name: Testing Lab

Entry 18 - fullUrl = urn:uuid:01a5777c-4b48-a0df-2963-02cd63339006

Resource DiagnosticReport:

Batch Analysis Report
When For 2020-12
Report Details
Code Value Note When For
Description Pass 2023-01-01 12:00:00+0000
Description Pass 2023-01-01 12:00:00+0000
Description Pass 2023-01-01 12:00:00+0000
Identification Conforms 2023-01-01 12:00:00+0000
Identification Does not conform 2023-01-01 12:00:00+0000
Identification Conforms 2023-01-01 12:00:00+0000
Assay 94 % CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0% 2023-01-01 12:00:00+0000
Assay 95 % CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0% 2023-01-01 12:00:00+0000
Assay 96 % CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0% 2023-01-01 12:00:00+0000
Impurities 0.5 % w/w 2023-01-01 12:00:00+0000
Impurities 0.4 % w/w 2023-01-01 12:00:00+0000
Impurities 0.2 % w/w 2023-01-01 12:00:00+0000
Impurities 0.5 % w/w 2023-01-01 12:00:00+0000
Impurities 0.4 % w/w 2023-01-01 12:00:00+0000
Impurities 0.2 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Impurities 0.5 % w/w 2023-01-01 12:00:00+0000
Impurities 0.4 % w/w 2023-01-01 12:00:00+0000
Impurities 0.2 % w/w 2023-01-01 12:00:00+0000
Impurities 0.5 % w/w 2023-01-01 12:00:00+0000
Impurities 0.4 % w/w 2023-01-01 12:00:00+0000
Impurities 0.2 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.1 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Impurities 0.02 % w/w 2023-01-01 12:00:00+0000
Mutagenic impurities 20 ppm 2023-01-01 12:00:00+0000
Mutagenic 22 % 2023-01-01 12:00:00+0000
Mutagenic 18 % 2023-01-01 12:00:00+0000
Enantiomeric purity 91.5 % CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0% 2023-01-01 12:00:00+0000
Enantiomeric purity 91.5 % CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0% 2023-01-01 12:00:00+0000
Enantiomeric purity 91.5 % Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use. 2023-01-01 12:00:00+0000
Residual solvents 0.1 % w/w 2023-01-01 12:00:00+0000
Residual solvents 0.1 % w/w 2023-01-01 12:00:00+0000
Residual solvents 0.1 % w/w 2023-01-01 12:00:00+0000
Residual solvents 1.4 % w/w 2023-01-01 12:00:00+0000
Residual solvents 1.5 % w/w 2023-01-01 12:00:00+0000
Residual solvents 1.2 % w/w 2023-01-01 12:00:00+0000
Water Content 0.8 % w/w 2023-01-01 12:00:00+0000
Water Content 0.8 % w/w 2023-01-01 12:00:00+0000
Water Content 0.8 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.5 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.4 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.2 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.5 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.4 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.2 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.1 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.1 % w/w 2023-01-01 12:00:00+0000
Particle size distribution 0.1 % w/w 2023-01-01 12:00:00+0000
The samples have been assessed and the conclusion is...

Entry 19 - fullUrl = urn:uuid:81f552f9-8458-3cf4-8379-eea5417a9de2

Resource Observation:

Generated Narrative: Observation
Resource Observation "81f552f9-8458-3cf4-8379-eea5417a9de2"
instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Pass ()

Entry 20 - fullUrl = urn:uuid:50bf6f69-a3f5-678b-469b-c5df5cca4c86

Resource Observation:

Generated Narrative: Observation
Resource Observation "50bf6f69-a3f5-678b-469b-c5df5cca4c86"
instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Pass ()

Entry 21 - fullUrl = urn:uuid:145fd3b7-3678-867f-4298-a6c781b86de3

Resource Observation:

Generated Narrative: Observation
Resource Observation "145fd3b7-3678-867f-4298-a6c781b86de3"
instantiates: See above (ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f)
status: FINAL
code: Description (CodeSystem - Example Local Codes - Drug#DESC)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Pass ()

Entry 22 - fullUrl = urn:uuid:55c89944-60d1-4eea-a2c3-6c53e3622bc5

Resource Observation:

Generated Narrative: Observation
Resource Observation "55c89944-60d1-4eea-a2c3-6c53e3622bc5"
instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Conforms ()

Entry 23 - fullUrl = urn:uuid:adb51ab6-00a9-1078-69e5-d32c025a857c

Resource Observation:

Generated Narrative: Observation
Resource Observation "adb51ab6-00a9-1078-69e5-d32c025a857c"
instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Does not conform ()

Entry 24 - fullUrl = urn:uuid:916a0ae2-9c43-72f0-a22a-c5f8ce902125

Resource Observation:

Generated Narrative: Observation
Resource Observation "916a0ae2-9c43-72f0-a22a-c5f8ce902125"
instantiates: See above (ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230)
status: FINAL
code: Identification (CodeSystem - Example Local Codes - Drug#IDT)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: Conforms ()

Entry 25 - fullUrl = urn:uuid:6deb4306-1193-24ae-a565-f73225652bdd

Resource Observation:

Generated Narrative: Observation
Resource Observation "6deb4306-1193-24ae-a565-f73225652bdd"
instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 94 % (Details: UCUM code % = '%')
note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

Entry 26 - fullUrl = urn:uuid:f6aabd2f-5902-57e7-6126-eccd9158a5b5

Resource Observation:

Generated Narrative: Observation
Resource Observation "f6aabd2f-5902-57e7-6126-eccd9158a5b5"
instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 95 % (Details: UCUM code % = '%')
note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

Entry 27 - fullUrl = urn:uuid:32f598e4-a0e0-98dc-41dd-0f8397f953ad

Resource Observation:

Generated Narrative: Observation
Resource Observation "32f598e4-a0e0-98dc-41dd-0f8397f953ad"
instantiates: See above (ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838)
status: FINAL
code: Assay (CodeSystem - Example Local Codes - Drug#ASSAY)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 96 % (Details: UCUM code % = '%')
note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

Entry 28 - fullUrl = urn:uuid:02d9e6be-833c-1c6d-a64a-baa3935c959d

Resource Observation:

Generated Narrative: Observation
Resource Observation "02d9e6be-833c-1c6d-a64a-baa3935c959d"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 1 ()

Entry 29 - fullUrl = urn:uuid:d3e572b7-14fd-744b-4123-58741d75571e

Resource Observation:

Generated Narrative: Observation
Resource Observation "d3e572b7-14fd-744b-4123-58741d75571e"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 1 ()

Entry 30 - fullUrl = urn:uuid:fe6ca484-a755-9a0b-a074-b6ee0a907ff8

Resource Observation:

Generated Narrative: Observation
Resource Observation "fe6ca484-a755-9a0b-a074-b6ee0a907ff8"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 1 ()

Entry 31 - fullUrl = urn:uuid:da92c71f-a12a-1980-11a3-80e3d1852244

Resource Observation:

Generated Narrative: Observation
Resource Observation "da92c71f-a12a-1980-11a3-80e3d1852244"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

Entry 32 - fullUrl = urn:uuid:8bf75da1-9221-66fe-6725-c64cb45a57e6

Resource Observation:

Generated Narrative: Observation
Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

Entry 33 - fullUrl = urn:uuid:31bfeff4-4a7d-3be5-878e-fb674d3d5487

Resource Observation:

Generated Narrative: Observation
Resource Observation "31bfeff4-4a7d-3be5-878e-fb674d3d5487"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 2 ()

Entry 34 - fullUrl = urn:uuid:732237a9-4b3b-27cc-99ca-6b913e622a29

Resource Observation:

Generated Narrative: Observation
Resource Observation "732237a9-4b3b-27cc-99ca-6b913e622a29"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 3 ()

Entry 35 - fullUrl = urn:uuid:52afbeb4-4958-a275-a0ca-d70b2b5240ec

Resource Observation:

Generated Narrative: Observation
Resource Observation "52afbeb4-4958-a275-a0ca-d70b2b5240ec"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 3 ()

Entry 36 - fullUrl = urn:uuid:7fc395b1-59e4-78be-0512-cf92133c0fac

Resource Observation:

Generated Narrative: Observation
Resource Observation "7fc395b1-59e4-78be-0512-cf92133c0fac"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity 3 ()

Entry 37 - fullUrl = urn:uuid:9c98bd8a-7dda-2f01-0dbd-8c60b60e8572

Resource Observation:

Generated Narrative: Observation
Resource Observation "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any individual unspecified impurity ()

Entry 38 - fullUrl = urn:uuid:97b16ff8-8e0f-915a-9d65-7fab108f40c2

Resource Observation:

Generated Narrative: Observation
Resource Observation "97b16ff8-8e0f-915a-9d65-7fab108f40c2"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any individual unspecified impurity ()

Entry 39 - fullUrl = urn:uuid:0244eafe-3126-909b-7d8d-4253f45f525c

Resource Observation:

Generated Narrative: Observation
Resource Observation "0244eafe-3126-909b-7d8d-4253f45f525c"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Any individual unspecified impurity ()

Entry 40 - fullUrl = urn:uuid:10b80cbd-45d3-9be1-63b9-29f04b47376c

Resource Observation:

Generated Narrative: Observation
Resource Observation "10b80cbd-45d3-9be1-63b9-29f04b47376c"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total impurities ()

Entry 41 - fullUrl = urn:uuid:84f015ac-9572-324f-8013-0b999cc95bbd

Resource Observation:

Generated Narrative: Observation
Resource Observation "84f015ac-9572-324f-8013-0b999cc95bbd"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total impurities ()

Entry 42 - fullUrl = urn:uuid:987daeaa-4c2a-72b7-780f-4a9403163a3e

Resource Observation:

Generated Narrative: Observation
Resource Observation "987daeaa-4c2a-72b7-780f-4a9403163a3e"
instantiates: See above (ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8)
status: FINAL
code: Impurities (CodeSystem - Example Local Codes - Drug#Impurities)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Total impurities ()

Entry 43 - fullUrl = urn:uuid:ff26533d-88a8-7f18-a275-42dc1373a388

Resource Observation:

Generated Narrative: Observation
Resource Observation "ff26533d-88a8-7f18-a275-42dc1373a388"
instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)
status: FINAL
code: Mutagenic impurities (CodeSystem - Example Local Codes - Drug#MUT)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 20 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) Impurity - Mutagenic ()

Entry 44 - fullUrl = urn:uuid:c99666d2-7962-9a71-58f6-7b2e5aa662f5

Resource Observation:

Generated Narrative: Observation
Resource Observation "c99666d2-7962-9a71-58f6-7b2e5aa662f5"
instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)
status: FINAL
code: Mutagenic (CodeSystem - Example Local Codes - Drug#MUT "Mutagenic impurities")
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 22 % (Details: UCUM code % = '%')

Entry 45 - fullUrl = urn:uuid:c18e21d3-7113-4d08-4ff3-0c9718596f64

Resource Observation:

Generated Narrative: Observation
Resource Observation "c18e21d3-7113-4d08-4ff3-0c9718596f64"
instantiates: See above (ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b)
status: FINAL
code: Mutagenic (CodeSystem - Example Local Codes - Drug#MUT "Mutagenic impurities")
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 18 % (Details: UCUM code % = '%')

Entry 46 - fullUrl = urn:uuid:66fdac46-2a6b-a66f-891b-8dcf67cc46c7

Resource Observation:

Generated Narrative: Observation
Resource Observation "66fdac46-2a6b-a66f-891b-8dcf67cc46c7"
instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)
status: FINAL
code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 91.5 % (Details: UCUM code % = '%')
note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

Entry 47 - fullUrl = urn:uuid:8306cfc5-158f-1a53-a683-048b226060d9

Resource Observation:

Generated Narrative: Observation
Resource Observation "8306cfc5-158f-1a53-a683-048b226060d9"
instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)
status: FINAL
code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 91.5 % (Details: UCUM code % = '%')
note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%

Entry 48 - fullUrl = urn:uuid:fc49ad55-07d1-997d-6695-bbff44746e75

Resource Observation:

Generated Narrative: Observation
Resource Observation "fc49ad55-07d1-997d-6695-bbff44746e75"
instantiates: See above (ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87)
status: FINAL
code: Enantiomeric purity (CodeSystem - Example Local Codes - Drug#enantiomeric-purity)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 91.5 % (Details: UCUM code % = '%')
note: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.

Entry 49 - fullUrl = urn:uuid:f8160692-a7a8-3fa6-9f35-e7df35f51ac0

Resource Observation:

Generated Narrative: Observation
Resource Observation "f8160692-a7a8-3fa6-9f35-e7df35f51ac0"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
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
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 1 ()

Entry 50 - fullUrl = urn:uuid:a531aee9-4c21-06af-352c-a3615b5d957e

Resource Observation:

Generated Narrative: Observation
Resource Observation "a531aee9-4c21-06af-352c-a3615b5d957e"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
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
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 1 ()

Entry 51 - fullUrl = urn:uuid:033ce81d-5f0d-7a3e-93d3-fc64e122a1fd

Resource Observation:

Generated Narrative: Observation
Resource Observation "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 1 ()

Entry 52 - fullUrl = urn:uuid:ba8a182e-8571-6cbd-047b-612735d599d2

Resource Observation:

Generated Narrative: Observation
Resource Observation "ba8a182e-8571-6cbd-047b-612735d599d2"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.4 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 2 ()

Entry 53 - fullUrl = urn:uuid:0b5b94cc-7a1a-4ada-66c7-954ceb528d67

Resource Observation:

Generated Narrative: Observation
Resource Observation "0b5b94cc-7a1a-4ada-66c7-954ceb528d67"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.5 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 2 ()

Entry 54 - fullUrl = urn:uuid:6afaacee-11a6-58b2-47df-5f79722c66ac

Resource Observation:

Generated Narrative: Observation
Resource Observation "6afaacee-11a6-58b2-47df-5f79722c66ac"
instantiates: See above (ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8)
status: FINAL
code: Residual solvents (CodeSystem - Example Local Codes - Drug#SOL)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 1.2 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Solvent (CodeSystem - Example Local Codes - Drug#SOLV) Solvent 2 ()

Entry 55 - fullUrl = urn:uuid:c2644a86-1684-286e-00e2-dcaf907a8970

Resource Observation:

Generated Narrative: Observation
Resource Observation "c2644a86-1684-286e-00e2-dcaf907a8970"
instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)
status: FINAL
code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
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 % = '%')

Entry 56 - fullUrl = urn:uuid:cb5f6872-6eeb-727a-7c33-f2c438581a1c

Resource Observation:

Generated Narrative: Observation
Resource Observation "cb5f6872-6eeb-727a-7c33-f2c438581a1c"
instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)
status: FINAL
code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
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 % = '%')

Entry 57 - fullUrl = urn:uuid:7faaf980-7c10-7b9a-9572-1bacd485824e

Resource Observation:

Generated Narrative: Observation
Resource Observation "7faaf980-7c10-7b9a-9572-1bacd485824e"
instantiates: See above (ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4)
status: FINAL
code: Water Content (CodeSystem - Example Local Codes - Drug#WaterContent)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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 % = '%')

Entry 58 - fullUrl = urn:uuid:e4d2118a-8562-9eb1-2c14-4e145d2a95fc

Resource Observation:

Generated Narrative: Observation
Resource Observation "e4d2118a-8562-9eb1-2c14-4e145d2a95fc"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) D(v,0.9) ()

Entry 59 - fullUrl = urn:uuid:ec078717-9512-4db4-77c6-2c7e29d213a6

Resource Observation:

Generated Narrative: Observation
Resource Observation "ec078717-9512-4db4-77c6-2c7e29d213a6"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Impurity (CodeSystem - Example Local Codes - Drug#IMP) D(v,0.9) ()

Entry 60 - fullUrl = urn:uuid:05cfb495-2580-561a-688d-ce6ea24c8962

Resource Observation:

Generated Narrative: Observation
Resource Observation "05cfb495-2580-561a-688d-ce6ea24c8962"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.9) ()

Entry 61 - fullUrl = urn:uuid:d2a60ae5-96b4-3d13-38da-729c652347a3

Resource Observation:

Generated Narrative: Observation
Resource Observation "d2a60ae5-96b4-3d13-38da-729c652347a3"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.5) ()

Entry 62 - fullUrl = urn:uuid:c3f51325-2f5f-194c-919b-2219ee1f5c45

Resource Observation:

Generated Narrative: Observation
Resource Observation "c3f51325-2f5f-194c-919b-2219ee1f5c45"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
effective: 2023-01-01 12:00:00+0000
performer: See above (Organization/378fbe5f-5926-3a5c-4c64-5428df877b08)
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.5) ()

Entry 63 - fullUrl = urn:uuid:e9d89693-11b1-13ed-5cde-606fc1b8372c

Resource Observation:

Generated Narrative: Observation
Resource Observation "e9d89693-11b1-13ed-5cde-606fc1b8372c"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.5) ()

Entry 64 - fullUrl = urn:uuid:2659b000-96e2-1b8b-129b-0c00e1074b0f

Resource Observation:

Generated Narrative: Observation
Resource Observation "2659b000-96e2-1b8b-129b-0c00e1074b0f"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1)
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
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.1) ()

Entry 65 - fullUrl = urn:uuid:10b47328-36fa-343d-5699-5b32b30a6d33

Resource Observation:

Generated Narrative: Observation
Resource Observation "10b47328-36fa-343d-5699-5b32b30a6d33"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
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
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.1) ()

Entry 66 - fullUrl = urn:uuid:e6780766-317a-382f-92d2-79825f506cc5

Resource Observation:

Generated Narrative: Observation
Resource Observation "e6780766-317a-382f-92d2-79825f506cc5"
instantiates: See above (ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4)
status: FINAL
code: Particle size distribution (CodeSystem - Example Local Codes - Drug#PART)
subject: See above (Substance/ef17cff1-6586-a4a4-9168-2602140548d7)
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
- Code Value[x]
* Particle Size (CodeSystem - Example Local Codes - Drug#SIZE) D(v,0.1) ()