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 title: Release code: Timing Group () timing: Code: Release time action action action action action action action action action title: End of shelf life code: Timing Group () timing: Code: At end of shelf life action action action action action action action action
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 *
An orange film-coated tablet, debossed with 175 on one side
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 *
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 *
Consistent with the retention time and UV spectrum of the reference standard
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 *
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 *
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 *
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)
Individual unspecified degradation products
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)
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 *
Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes
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 *
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
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
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 *
Shall comply with the requirements of the Ph Eur
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 *
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 *
Shall comply with the requirements of the harmonised USP/JP/Ph Eur
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 *
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)
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
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152" manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" 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