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 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
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 (Pharmaceutical Plan Type Codes#1244577)
status: ACTIVE
subject: See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
description: Narrative description of analysis
action
title: Batch Specification for Drug Substance
code: Overall set of actions ()
Actions
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 (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 (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 (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 (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 (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 (Example Local Codes - Drug#MUT)
method: Impurity 5 content by LC-MS ()
QualifiedValues
AppliesTo Range Impurity - Mutagenic () ?-50 Components
Code Impurity (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 (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 (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 (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 (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 (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 (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 on this page: 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 on this page: PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975
Extension - Actual Yield PQ: 4.8 kg
identifier: CAT1
instance: true
Codes
Reference See on this page: 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 on this page: 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: CAT2
instance: true
Codes
Reference See on this page: 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 on this page: 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: CAT3
instance: true
Codes
Reference See on this page: 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 (Pharmaceutical Plan Type Codes#1244566)
status: ACTIVE
subject: See on this page: 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 on this page: 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:
urn:oid:2.16.840.1.113883.4.82
/3003040516active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
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"
identifier:
urn:oid:2.16.840.1.113883.4.82
/3007270600active: true
type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release)
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 on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f
status: FINAL
code: Description (Example Local Codes - Drug#DESC)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230
status: FINAL
code: Identification (Example Local Codes - Drug#IDT)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838
status: FINAL
code: Assay (Example Local Codes - Drug#ASSAY)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8
status: FINAL
code: Impurities (Example Local Codes - Drug#Impurities)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.02 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status: FINAL
code: Mutagenic impurities (Example Local Codes - Drug#MUT)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 20 ppm (Details: UCUM code [ppm] = '[ppm]')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status: FINAL
code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities")
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b
status: FINAL
code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities")
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status: FINAL
code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status: FINAL
code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87
status: FINAL
code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 1.4 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 1.5 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8
status: FINAL
code: Residual solvents (Example Local Codes - Drug#SOL)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 1.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Solvent (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 on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
status: FINAL
code: Water Content (Example Local Codes - Drug#WaterContent)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
status: FINAL
code: Water Content (Example Local Codes - Drug#WaterContent)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4
status: FINAL
code: Water Content (Example Local Codes - Drug#WaterContent)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: 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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Impurity (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.5 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.4 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.2 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (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 on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
status: FINAL
code: Particle size distribution (Example Local Codes - Drug#PART)
subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7
effective: 2023-01-01 12:00:00+0000
performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08
value: 0.1 % w/w (Details: UCUM code % = '%')
Components
Code Value[x] Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()