Generated Narrative: DiagnosticReport Resource DiagnosticReport "diagnosticreport-analysis-drug-pq-stability-prod" Profile: DiagnosticReport - Analysis Drug PQ Triggered by: See on this page: PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54 Extension - Statistical Model PQ: information about statistical model utilized to interpret stability study results () Extension - Container Orientation PQ: Horizontal (Container Orientation Codes#horizontal "horizontal") identifier: https://eudract.europa.eu/example/identifier/ABC1234 status: final code: Stability Study Report - 18 months (Pharmaceutical Report Type Codes#Stability Study Report - 18 months) effective: 2020-12 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 result: See on this page: Observation/6fabbf78-9678-8030-485f-b149956308d5 See on this page: Observation/74535cc6-5232-5ab5-81cf-167a480795e5 See on this page: Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6 See on this page: Observation/e803ad6d-0cb3-87dd-6af1-4b88c654a47c See on this page: Observation/3519f84a-2889-90a0-a6b7-ff2f1be66a73 See on this page: Observation/2ef362f1-0b65-3578-7f06-fbd74a24694a See on this page: Observation/72e0640b-094b-909e-5268-3dee92af4bbd conclusion: The samples have been assessed and the conclusion is that the shelf life can be 18 months.
information about statistical model utilized to interpret stability study results
The samples have been assessed and the conclusion is that the shelf life can be 18 months.
Generated Narrative: PlanDefinition Resource PlanDefinition "c96cb248-1408-79fc-1f47-b17a6b2e4b54" Profile: PlanDefinition - Drug PQ url: http://example-server.com/fhir/PlanDefinition/c96cb248-1408-79fc-1f47-b17a6b2e4b54 title: Stability Monitoring Program type: Stability Study Protocol (Pharmaceutical Plan Type Codes#1244588) status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Narrative description of Stability Study action title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg action title: Long-Term description: 25°C/60% RH action action action action action action action action title: Accelerated description: 40°C/75% RH action action action action action action action
Narrative description of Stability Study
Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg
Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" Profile: SpecimenDefinition - Drug PQ url: http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 status: active typeTested preference: preferred Handlings - Instruction * 25°C/60% RH
Generated Narrative: ActivityDefinition Resource ActivityDefinition "610ca25c-6126-6117-8d4d-9458ccc33ce2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/610ca25c-6126-6117-8d4d-9458ccc33ce2 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
Generated Narrative: ActivityDefinition Resource ActivityDefinition "d99c1b63-2d32-4887-8157-525cc8ae4732" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/d99c1b63-2d32-4887-8157-525cc8ae4732 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
Generated Narrative: ActivityDefinition Resource ActivityDefinition "38704856-0acf-95f0-000f-a933b6862fa0" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/38704856-0acf-95f0-000f-a933b6862fa0 title: Long-term - 25°C/60% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774
Generated Narrative: ActivityDefinition Resource ActivityDefinition "4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 title: Long-term - 25°C/60% RH - XYZ status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851, http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409
Generated Narrative: ActivityDefinition Resource ActivityDefinition "f19a68b0-4ba1-7288-635e-12783035935b" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/f19a68b0-4ba1-7288-635e-12783035935b title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
Generated Narrative: ActivityDefinition Resource ActivityDefinition "ce2df6ab-5087-435c-35cb-a84572e756a2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
Generated Narrative: ActivityDefinition Resource ActivityDefinition "cf2df6ab-5087-435c-35cb-a84572e756a2" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/cf2df6ab-5087-435c-35cb-a84572e756a2 title: Long-term - 25°C/60% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774, http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851
Generated Narrative: ObservationDefinition Resource ObservationDefinition "d1d252cf-9d58-43a0-85f6-56a7f7f92774" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/d1d252cf-9d58-43a0-85f6-56a7f7f92774 title: X status: active code: Battery of tests 'X' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
Generated Narrative: ObservationDefinition Resource ObservationDefinition "1178fc31-0cfd-8c60-0b5b-9ae2850c6774" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 title: Description status: active code: Description (Example Local Codes - Drug#DESC) QualifiedValues - Extension *
An orange film-coated tablet, debossed with 175 on one side
Generated Narrative: ObservationDefinition Resource ObservationDefinition "2c5683d6-6e94-825b-056a-129a04c95e2f" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f title: Degradation Products by HPLC (% w/w) 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: Any Unspecified Degradation Impurity () range: ?-0.2 qualifiedValue appliesTo: Total Degradation Impurities () range: ?-2.3 Components - Code * Impurity (Example Local Codes - Drug#IMP)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "186eb33e-a01d-4252-166c-b5ba5e8a697c" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c title: Water Content (% w/w) (Mean) status: active code: Water Content (Example Local Codes - Drug#WaterContent) QualifiedValues - Range * ?-0.2
Generated Narrative: ObservationDefinition Resource ObservationDefinition "b62b9524-53af-84ae-1071-2867a2169851" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/b62b9524-53af-84ae-1071-2867a2169851 title: Y status: active code: Battery of tests 'Y' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
Generated Narrative: ObservationDefinition Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e title: Microbiological status: active code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "363384c8-0d79-5ff0-5538-4933f99d6409" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/363384c8-0d79-5ff0-5538-4933f99d6409 title: Z status: active code: Battery of tests 'Z' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 hasMember: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef781c18-8e86-7859-209b-469ee9ad42d8" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 title: Uniformity of dosage status: active code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) QualifiedValues - Extension *
Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "e95109ac-5ef9-1723-3506-2ef2f2e33d87" url: http://example-server.com/fhir/SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 status: active typeTested preference: preferred Handlings - Instruction * 40°C/75% RH
Generated Narrative: ActivityDefinition Resource ActivityDefinition "096e3f32-798e-6792-76ad-4ea783521c50" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50 title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
Generated Narrative: ActivityDefinition Resource ActivityDefinition "77f86b13-8193-3df7-8362-ab5e79ba541d" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/77f86b13-8193-3df7-8362-ab5e79ba541d title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b
Generated Narrative: ActivityDefinition Resource ActivityDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" Profile: ActivityDefinition - Test Drug PQ url: http://example-server.com/fhir/ActivityDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b title: Accelerated - 40°C/70% RH - XYZ status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b, http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2, http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0
Generated Narrative: ObservationDefinition Resource ObservationDefinition "792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/792ae02e-5ba3-13d1-8cc2-fd24a22f7f0b title: X status: active code: Battery of tests 'X' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c
Generated Narrative: ObservationDefinition Resource ObservationDefinition "58cb0710-0ee6-1b7a-2a64-61a01df95ac2" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/58cb0710-0ee6-1b7a-2a64-61a01df95ac2 title: Y status: active code: Battery of tests 'Y' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
Generated Narrative: ObservationDefinition Resource ObservationDefinition "9bc183ee-6017-789b-8a6f-6a5c339f9ae0" Profile: ObservationDefinition - Test Method PQ url: http://example-server.com/fhir/ObservationDefinition/9bc183ee-6017-789b-8a6f-6a5c339f9ae0 title: Z status: active code: Battery of tests 'Z' at 25°C/60% RH () specimen: See on this page: SpecimenDefinition/e95109ac-5ef9-1723-3506-2ef2f2e33d87 hasMember: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8
Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955bd" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-01 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928a-5def2a9955be" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-02 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Specimen Resource Specimen "b664977d-799d-a1ce-928b-5def2a9955be" Profile: Specimen - Drug PQ Collections - Collected[x] * 2020-12-03 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Observation Resource Observation "6fabbf78-9678-8030-485f-b149956308d5" Profile: Observation - Test Result Drug PQ Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928a-5def2a9955bd hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.801 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () instantiates: See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1501 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-1-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #observation-test-result-lt25c-i1-degradation-imp1 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp2 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-imp3 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impUnspecified instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () Generated Narrative: Observation #LongTerm25C-initial-1-Degradation-impTotal instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.801 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () Generated Narrative: Observation #LongTerm25C-initial-1-Water instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1501 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm25C-initial-1-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-1-Uniformity instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies ()
Test Components - Long-term 25C etc - Initial (XYZ)
Generated Narrative: Observation Resource Observation "74535cc6-5232-5ab5-81cf-167a480795e5" Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928a-5def2a9955be hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-2-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-2-Degradation instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm25C-initial-2-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies Generated Narrative: Observation #LongTerm25C-initial-2-Uniformity instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies ()
Generated Narrative: Observation Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" Triggered by: See on this page: ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/b664977d-799d-a1ce-928b-5def2a9955be hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-3-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-3-Degradation instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm25C-initial-3-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-initial-3-Uniformity instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies ()
Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c78" Collections - Collected[x] * 2020-12-01 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c88" Collections - Collected[x] * 2020-12-02 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
Generated Narrative: Specimen Resource Specimen "18826818-10c4-972c-618e-01694ff06c89" Collections - Collected[x] * 2020-12-03 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 25°C/60% RH
Generated Narrative: Observation Resource Observation "e803ad6d-0cb3-87dd-6af1-4b88c654a47c" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c78 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () instantiates: See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1518 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-1-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp1 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp2 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-imp3 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impUnspecified instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () Generated Narrative: Observation #LongTerm25C-18m-1-Degradation-impTotal instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () Generated Narrative: Observation #LongTerm25C-18m-1-Water instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1518 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm25C-18m-1-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies Generated Narrative: Observation #LongTerm25C-18m-1-Uniformity instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies ()
Test Components - Long-term 25C etc - 18 months (XY)
Generated Narrative: Observation Resource Observation "3519f84a-2889-90a0-a6b7-ff2f1be66a73" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c88 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply Generated Narrative: Observation #LongTerm25C-18m-2-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-2-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/8306cfc5-158f-1a53-a683-048b226060d9 effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply
Generated Narrative: Observation Resource Observation "2ef362f1-0b65-3578-7f06-fbd74a24694a" Triggered by: See on this page: ActivityDefinition/ce2df6ab-5087-435c-35cb-a84572e756a2 status: final code: Test Components - Long-term 25C etc - 18 months (XY) () subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/18826818-10c4-972c-618e-01694ff06c89 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply Generated Narrative: Observation #LongTerm25C-18m-3-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #LongTerm25C-18m-3-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/f54d4666-7ae3-4e30-8c5a-6d13838c4f3b effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Does not comply
Generated Narrative: Specimen Resource Specimen "8a7771db-5cc0-33f8-966a-b2f792bf5785" Collections - Collected[x] * 2020-12-01 processing description: Store for 3 months time: 2020-12 --> 2021-03 processing description: 40°C/75% RH
Generated Narrative: Observation Resource Observation "72e0640b-094b-909e-5268-3dee92af4bbd" Triggered by: See on this page: ActivityDefinition/096e3f32-798e-6792-76ad-4ea783521c50 status: final code: Test Components - Accelerated 40C etc - 3 Months (X) () subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 specimen: See on this page: Specimen/8a7771db-5cc0-33f8-966a-b2f792bf5785 hasMember: instantiates: See on this page: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.143 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.243 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () instantiates: See on this page: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.801 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () instantiates: See on this page: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1501 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () instantiates: See on this page: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #Accelerated40C-3-1-Description instantiates: ObservationDefinition/1178fc31-0cfd-8c60-0b5b-9ae2850c6774 status: final code: Description (Example Local Codes - Drug#DESC) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp1 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.143 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 () Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp2 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.243 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #Accelerated40C-3-1-Degradation-imp3 instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.201 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 () Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impUnspecified instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <0.101 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Degradation Impurity () Generated Narrative: Observation #Accelerated40C-3-1-Degradation-impTotal instantiates: ObservationDefinition/2c5683d6-6e94-825b-056a-129a04c95e2f status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.801 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Degradation Impurities () Generated Narrative: Observation #Accelerated40C-3-1-Water instantiates: ObservationDefinition/186eb33e-a01d-4252-166c-b5ba5e8a697c status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 0.1501 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #Accelerated40C-3-1-Microbiological instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies () Generated Narrative: Observation #Accelerated40C-3-1-Uniformity instantiates: ObservationDefinition/ef781c18-8e86-7859-209b-469ee9ad42d8 status: final code: Uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: Medication/7ef62d57-7cc6-9211-66d6-abc7e096093c effective: 2023-01-01 12:00:00+0000 performer: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: Complies ()
Test Components - Accelerated 40C etc - 3 Months (X)
Generated Narrative: Medication Resource Medication "7ef62d57-7cc6-9211-66d6-abc7e096093c" Profile: Medication - Batch Information Drug PQ code: () Batches - Extension LotNumber * , , , , , 33445
Generated Narrative: Medication Resource Medication "8306cfc5-158f-1a53-a683-048b226060d9" code: () Batches - Extension LotNumber * , , , , , 33446
Generated Narrative: Medication Resource Medication "f54d4666-7ae3-4e30-8c5a-6d13838c4f3b" code: () Batches - Extension LotNumber * , , , , , 33447
Generated Narrative: Organization Resource Organization "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" identifier: urn:oid:2.16.840.1.113883.4.82/3010027650 active: true type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture) name: AAA Pharmaceutical, Inc. Contacts - Address * 681 Main Street Lumberton New Jersey 08048 USA
Generated Narrative: Organization Resource Organization "2dd49242-4bf1-9ec1-5f1e-22ba8d4d5ccc" identifier: urn:oid:2.16.840.1.113883.4.82/3008816891 active: true type: Packaging (Pharmaceutical Organization Type Codes#packaging) name: MySite
Generated Narrative: Organization Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability) name: Advanced Analytical Testing Laboratories Inc. Contacts - Address * 30 Silverline Drive North Brunswick New Jersey 08902 USA
Advanced Analytical Testing Laboratories Inc.
Generated Narrative: MedicinalProductDefinition Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" Profile: MedicinalProductDefinition - Drug Product PQ 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" Profile: Ingredient - Drug Pq 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/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "57a9af63-315d-1585-a261-0e337b289390" Profile: SubstanceDefinition - Component Substance Drug PQ manufacturer: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "49d2f0c0-4b28-9271-8aaf-2996a8b9739c" Profile: Organization - Drug PQ 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
Generated Narrative: Substance Resource Substance "fc078762-81c5-5656-9744-13c7ad1e595b" Profile: Substance - Drug PQ Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: true Codes - Reference * See on this page: SubstanceDefinition/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "cb31d747-2338-88d5-342c-8e9c097e4dad" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c 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/57a9af63-315d-1585-a261-0e337b289390
Generated Narrative: Substance Resource Substance "1551f97b-6f6d-825e-1fb3-44b0b090808c" Medication Manufacturing Batch url manufacturingDate value: 2019-09-07 url batchQuantity value: 5 kg url batchUtilization value: Development (NCI Thesaurus#C133991) url assignedManufacturer value: See on this page: Organization/49d2f0c0-4b28-9271-8aaf-2996a8b9739c 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/57a9af63-315d-1585-a261-0e337b289390