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-product-specification-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a
Resource PlanDefinition:
Generated Narrative: PlanDefinition
Resource PlanDefinition "plandefinition-drug-pq-ex3-drug-specification"
url:
http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a
title: SPECIFICATION(S) FOR DRUG PRODUCT
status: ACTIVE
subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
description: Narrative description of specifications
action
title: Specification(s) for Drug Product
code: Overall set of actions ()
action
action
Entry 2 - fullUrl = urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "77e7020a-270c-6bed-2e55-28e9e942546c"
url:
http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c
title: Description
status: ACTIVE
code: Description (Example Local Codes - Drug#DESC)
method: Visual inspection ()
QualifiedValues
Extension
Entry 3 - fullUrl = urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "d24ce3cd-213d-4935-97cf-8e2dd03721ec"
url:
http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec
title: Description
status: ACTIVE
code: Description (Example Local Codes - Drug#DESC)
QualifiedValues
Extension
Entry 4 - fullUrl = urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"
url:
http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12
title: Identification
status: ACTIVE
code: Identification (Example Local Codes - Drug#IDT)
method: ID by UHPLC ()
QualifiedValues
Extension
Entry 5 - fullUrl = urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "f77ba972-5ef8-a178-9a5f-fe7f54da7499"
url:
http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499
title: Identification
status: ACTIVE
code: Identification (Example Local Codes - Drug#IDT)
QualifiedValues
Extension
Entry 6 - fullUrl = urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "c0f05343-5b98-6073-1a0f-873aaf4f59bc"
url:
http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc
title: Assay
status: ACTIVE
code: Assay (Example Local Codes - Drug#ASSAY)
method: Assay by UHPLC ()
QualifiedValues
Extension
Entry 7 - fullUrl = urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"
url:
http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f
title: Assay
status: ACTIVE
code: Assay (Example Local Codes - Drug#ASSAY)
QualifiedValues
Extension
Entry 8 - fullUrl = urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "a3d4d23a-800a-684a-6a47-fcfe44e06041"
url:
http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041
title: Degradation Products
status: ACTIVE
code: Degradation Products (Example Local Codes - Drug#DGP)
method: Degradation products by UHPLC ()
qualifiedValue
appliesTo: Impurity 1 ()
range: ?-0.2
qualifiedValue
appliesTo: Impurity 2 ()
range: ?-0.3
qualifiedValue
appliesTo: Impurity 3 ()
range: ?-0.3
qualifiedValue
appliesTo: Individual unspecified degradation products ()
range: ?-0.2
qualifiedValue
appliesTo: Total degradation products ()
range: ?-1.4
Components
Code Impurity (Example Local Codes - Drug#IMP)
Entry 9 - fullUrl = urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "ef72eeb7-211a-3c16-8460-8725ca43584f"
url:
http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f
title: Degradation Products
status: ACTIVE
code: Degradation Products (Example Local Codes - Drug#DGP)
qualifiedValue
appliesTo: Impurity 1 ()
range: ?-0.8
qualifiedValue
appliesTo: Impurity 2 ()
range: ?-0.4
qualifiedValue
appliesTo: Impurity 3 ()
range: ?-0.4
qualifiedValue
appliesTo: Individual unspecified degradation products ()
range: ?-2.3
qualifiedValue
appliesTo: Total degradation products ()
range: ?-2.3
Components
Code Impurity (Example Local Codes - Drug#IMP)
Entry 10 - fullUrl = urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "bb11322b-9470-4f13-91b5-c8a5253380eb"
url:
http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb
title: Dissolution
status: ACTIVE
code: Dissolution (Example Local Codes - Drug#Dissolution)
method: Apparatus 2 (paddles), UV measurement ()
QualifiedValues
Extension
Entry 11 - fullUrl = urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"
url:
http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea
title: Dissolution
status: ACTIVE
code: Dissolution (Example Local Codes - Drug#Dissolution)
method: Apparatus 2 (paddles), UV measurement ()
QualifiedValues
Extension
Entry 12 - fullUrl = urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"
url:
http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1
title: Water Content
status: ACTIVE
code: Water Content (Example Local Codes - Drug#WaterContent)
method: USP <921> ()
QualifiedValues
Range ?-1.0
Entry 13 - fullUrl = urn:uuid:91391017-774b-5c77-93fa-642534278851
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "91391017-774b-5c77-93fa-642534278851"
url:
http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851
title: Water Content
status: ACTIVE
code: Water Content (Example Local Codes - Drug#WaterContent)
method: USP <921> ()
QualifiedValues
Range ?-2.0
Entry 14 - fullUrl = urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64972eb3-99ee-7eae-2f63-733e5ae84f71"
url:
http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71
title: Microbiological
status: ACTIVE
code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality)
method: Ph Eur ()
QualifiedValues
Extension
Entry 15 - fullUrl = urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "e582e504-36ec-3b50-4043-51bf1147124e"
url:
http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e
title: Microbiological
status: ACTIVE
code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality)
method: Ph Eur ()
QualifiedValues
Extension
Entry 16 - fullUrl = urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "e7e2fe59-5433-5cc0-84b1-d5f30032790c"
url:
http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c
title: Uniformity of dosage
status: ACTIVE
code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage)
method: Weight variation ()
QualifiedValues
Extension
Entry 17 - fullUrl = urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "43dbc2a3-00c4-6f79-6b11-63768b412aa3"
url:
http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3
title: Uniformity of dosage
status: ACTIVE
code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage)
QualifiedValues
Extension
Entry 18 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
description: Textual description of the product
combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000)
route: Oral use (standardterms.edqm.eu#20053000)
name
productName: Stelbat Tablets, 20mg
type: Proprietary (Product Name Type - example#Proprietary)
Parts
Part Type 20mg Strength part (Product Name Part Type#StrengthPart)
Entry 19 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"
status: ACTIVE
for: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
role: Active (Ingredient Role#100000072072)
substance
Codes
Reference See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152
Entry 20 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"
manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Names
Name Stelbatolol
Entry 21 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d
Resource Organization:
Generated Narrative: Organization
Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"
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