Example: Bundle – Substance Specification - Pharmaceutical Quality (Industry) v1.0.0

Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Example Bundle: Example: Bundle – Substance Specification

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
- Code Definition[x]
* Test () http://example-server.com/fhir/ObservationDefinition/52176085-1f30-0c67-9ad7-523c486c82c9
* Test () http://example-server.com/fhir/ObservationDefinition/b50d892c-8980-0774-39d4-d449732873a3
* Test () http://example-server.com/fhir/ObservationDefinition/d460b561-110c-7eb6-5d69-788abcca391a
* Test () http://example-server.com/fhir/ObservationDefinition/006a9f7b-91ca-5601-38ef-a3dd26ad7121
* Test () http://example-server.com/fhir/ObservationDefinition/c59deb1b-835c-1be5-4e08-95dea3ae1a17
* Test () http://example-server.com/fhir/ObservationDefinition/18e20bae-1a24-202d-11d7-5f354c785e4d
* Test () http://example-server.com/fhir/ObservationDefinition/22544fa4-0fa2-1d5a-253d-a1fbe8fd61ce
* Test () http://example-server.com/fhir/ObservationDefinition/b4f736ff-1bbf-6923-4d5c-85d262285d7d
* Test () http://example-server.com/fhir/ObservationDefinition/233865df-2a71-528d-756c-85f36bd6685f

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:2.16.840.1.113883.4.82/3003040516
active: 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