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-drug-substance-specification-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
Resource PlanDefinition:
Generated Narrative: PlanDefinition
Resource PlanDefinition "specificationProtocol"
url:
http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
title: SPECIFICATION FOR DRUG SUBSTANCE
status: ACTIVE
subject: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-70f9-647b0ea97adb
description: Narrative description of specifications
action
title: Specification for Drug Substance
code: Overall set of actions ()
Actions
Entry 2 - fullUrl = urn:uuid:52176085-1f30-0c67-9ad7-523c486c82c9
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "52176085-1f30-0c67-9ad7-523c486c82c9"
url:
http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
title: Description
status: ACTIVE
code: Description (Example Local Codes - Drug#DESC)
method: Visual inspection ()
QualifiedValues
Extension
Entry 3 - fullUrl = urn:uuid:b50d892c-8980-0774-39d4-d449732873a3
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "b50d892c-8980-0774-39d4-d449732873a3"
url:
http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
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:d460b561-110c-7eb6-5d69-788abcca391a
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "d460b561-110c-7eb6-5d69-788abcca391a"
url:
http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
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:006a9f7b-91ca-5601-38ef-a3dd26ad7121
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "006a9f7b-91ca-5601-38ef-a3dd26ad7121"
url:
http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
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: 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:c59deb1b-835c-1be5-4e08-95dea3ae1a17
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "c59deb1b-835c-1be5-4e08-95dea3ae1a17"
url:
http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
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:18e20bae-1a24-202d-11d7-5f354c785e4d
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "18e20bae-1a24-202d-11d7-5f354c785e4d"
url:
http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
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:22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce"
url:
http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
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:b4f736ff-1bbf-6923-4d5c-85d262285d7d
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "b4f736ff-1bbf-6923-4d5c-85d262285d7d"
url:
http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
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:233865df-2a71-528d-756c-85f36bd6685f
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "233865df-2a71-528d-756c-85f36bd6685f"
url:
http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f
title: Particle size distribution
status: ACTIVE
code: Particle size distribution (Example Local Codes - Drug#particle-size-distribution)
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#particle-size)
Entry 11 - fullUrl = urn:uuid:03d68d1c-162c-8b6e-70f9-647b0ea97adb
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "03d68d1c-162c-8b6e-70f9-647b0ea97adb"
manufacturer: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620
Names
Name Stelbatolol
Entry 12 - fullUrl = urn:uuid:062bf235-44e2-55c4-9213-bbe5e12d5620
Resource Organization:
Generated Narrative: Organization
Resource Organization "062bf235-44e2-55c4-9213-bbe5e12d5620"
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