Generated Narrative: PlanDefinition Resource PlanDefinition "2038e4c7-22b8-4c56-2d28-6c077648763f" Profile: PlanDefinition - Drug PQ url: http://example-server.com/fhir/PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f title: P.5.4 BATCH ANALYSIS type: Specification Protocol (Pharmaceutical Plan Type Codes#1244577) status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5 description: Narrative description of analysis action title: Batch Specification 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 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 "fc07b5d5-9fe1-91c2-2d06-47cb5b295e72" url: http://example-server.com/fhir/ObservationDefinition/fc07b5d5-9fe1-91c2-2d06-47cb5b295e72 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 "220059d8-5aed-6d9e-563f-aac39b315c05" url: http://example-server.com/fhir/ObservationDefinition/220059d8-5aed-6d9e-563f-aac39b315c05 title: Description status: active code: Description (Example Local Codes - Drug#DESC) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "3b0e878e-4bc9-8864-862f-e28b21233e8d" url: http://example-server.com/fhir/ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d 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 "7c01a2fc-7ced-92b5-3ce7-8279d9df2421" url: http://example-server.com/fhir/ObservationDefinition/7c01a2fc-7ced-92b5-3ce7-8279d9df2421 title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "39ffd548-bb3d-43b9-9ca9-83f26631712b" url: http://example-server.com/fhir/ObservationDefinition/39ffd548-bb3d-43b9-9ca9-83f26631712b title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by UHPLC () QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "9d1fd19a-9265-7b02-865e-75c12e952ad4" url: http://example-server.com/fhir/ObservationDefinition/9d1fd19a-9265-7b02-865e-75c12e952ad4 title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "8bdea820-4197-7c7d-0990-7be06bf78aaf" url: http://example-server.com/fhir/ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf 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 "d5d084d0-37c9-3e1e-1d3f-97e7798540a9" url: http://example-server.com/fhir/ObservationDefinition/d5d084d0-37c9-3e1e-1d3f-97e7798540a9 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 "8f5d8abf-2cf4-8617-1e41-a74d90210dcc" url: http://example-server.com/fhir/ObservationDefinition/8f5d8abf-2cf4-8617-1e41-a74d90210dcc 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
Generated Narrative: ObservationDefinition Resource ObservationDefinition "33a9d578-6e6b-7606-72bc-6775d36c1930" url: http://example-server.com/fhir/ObservationDefinition/33a9d578-6e6b-7606-72bc-6775d36c1930 title: Dissolution (Q) status: active code: Dissolution Quantity (Example Local Codes - Drug#Dissolution Quantity) method: Apparatus 2 (paddles), UV measurement () QualifiedValues - Condition Range * at 30 minutes 80-? %
Generated Narrative: ObservationDefinition Resource ObservationDefinition "062bf235-44e2-55c4-9213-bbe5e12d5620" url: http://example-server.com/fhir/ObservationDefinition/062bf235-44e2-55c4-9213-bbe5e12d5620 title: Dissolution status: active code: Dissolution (Example Local Codes - Drug#Dissolution) method: Apparatus 2 (paddles), UV measurement () QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "31e29d22-5fcb-546e-24fd-52a4a4004467" url: http://example-server.com/fhir/ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 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 "7d0b63fc-5194-33d0-3e4a-0aef5edf7ba6" url: http://example-server.com/fhir/ObservationDefinition/7d0b63fc-5194-33d0-3e4a-0aef5edf7ba6 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 "d999ee06-6595-762c-1bda-0818ab1c6c0e" url: http://example-server.com/fhir/ObservationDefinition/d999ee06-6595-762c-1bda-0818ab1c6c0e 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 "60529d20-a55e-2575-4cb7-9f207ef8a2a1" url: http://example-server.com/fhir/ObservationDefinition/60529d20-a55e-2575-4cb7-9f207ef8a2a1 title: Microbiological status: active code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) method: Ph Eur () QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "ef17cff1-6586-a4a4-9168-2602140548d7" url: http://example-server.com/fhir/ObservationDefinition/ef17cff1-6586-a4a4-9168-2602140548d7 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 "2b01c026-1687-24c7-4c8c-e5d98ada8683" url: http://example-server.com/fhir/ObservationDefinition/2b01c026-1687-24c7-4c8c-e5d98ada8683 title: Uniformity of dosage status: active code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) QualifiedValues - Extension *
Generated Narrative: Medication Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" code: () Batches - Extension LotNumber * , , , , , 33445
Generated Narrative: Medication Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" code: () Batches - Extension LotNumber * , , , , , 33446
Generated Narrative: Medication Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" code: () Batches - Extension LotNumber * , , , , , 33447
Generated Narrative: Organization Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a" 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 "378fbe5f-5926-3a5c-4c64-5428df877b07" identifier: urn:oid:2.16.840.1.113883.4.82/3008816891 active: true type: Packaging (Pharmaceutical Organization Type Codes#packaging) name: MySite
Generated Narrative: DiagnosticReport Resource DiagnosticReport "batchAnalysisReport" Triggered by: See on this page: PlanDefinition/2038e4c7-22b8-4c56-2d28-6c077648763f status: final code: Batch Analysis Report (Pharmaceutical Report Type Codes#Batch Analysis Report) effective: 2020-12 result: See on this page: Observation/18c2d9e0-08c7-84e2-5e59-8f56321f895d See on this page: Observation/ba1b4227-8a67-a605-1152-e86e4d614fc3 See on this page: Observation/2d628dc2-0b9e-9494-55b3-2621e50938c5 See on this page: Observation/f0a04328-905c-4ec5-372e-4d6cfef18629 See on this page: Observation/5e5a5e67-7fc6-0064-1be9-5d9d14d887e5 See on this page: Observation/cfde6776-673c-72e2-68c4-07b77cd85b74 See on this page: Observation/9c56948a-1a39-6609-1c01-4d197ea57a33 See on this page: Observation/1e20aed7-7626-1664-8d96-235f860d9a2c See on this page: Observation/ec6d7e30-4d70-491b-0669-a613eedd3c60 See on this page: Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a See on this page: Observation/4052f28b-64a2-392d-35e4-ec8e912434d2 See on this page: Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c See on this page: Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913 See on this page: Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e See on this page: Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57 See on this page: Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795 See on this page: Observation/be016630-8754-7414-9014-21e020ad66c6 See on this page: Observation/92568f68-78f3-908c-6935-ff5f3d574dd6 See on this page: Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12 See on this page: Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745 See on this page: Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb See on this page: Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7 See on this page: Observation/6a78bcde-4781-226c-946e-a4b6915c1899 See on this page: Observation/f9f11088-7527-947c-3d3f-e71b32e13c78 See on this page: Observation/7316e094-2094-5710-4f11-75d3effc995e See on this page: Observation/1cedf9c1-8e89-5dbb-0e1f-0363a9ca4893 See on this page: Observation/c350f0b1-9495-0165-2555-83ebd79da682 See on this page: Observation/4b97e406-3fb0-9f65-0979-910ea1b9254f See on this page: Observation/bbfc28df-49bc-986c-1a0e-75e3160268b9 See on this page: Observation/d6955449-16b4-107f-851d-2f99d0b47b96 See on this page: Observation/591f5d75-1b2f-299b-6885-f325e4228bda See on this page: Observation/1dd8e506-08cf-8a15-8cd0-7c7cf1d88731 See on this page: Observation/ae0676b9-8ce4-7c72-135e-1fa9ea7f42c3 See on this page: Observation/d136c4f5-62da-81eb-4fc8-144f9182589e See on this page: Observation/3ab5e4eb-673b-0e66-3d2c-86d64ced0e86 See on this page: Observation/cec7ce65-57d7-a654-9ad6-21d162186eb9 See on this page: Observation/66c2f585-678e-78b8-2235-1a3b37bd6e46 See on this page: Observation/f8232d25-023d-679f-9c58-a6dc234b7a28 See on this page: Observation/368b82be-75dd-1d97-3dbc-a7eed9869daa conclusion: The samples have been assessed and the conclusion is...
The samples have been assessed and the conclusion is...
Generated Narrative: Observation Resource Observation "18c2d9e0-08c7-84e2-5e59-8f56321f895d" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "ba1b4227-8a67-a605-1152-e86e4d614fc3" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not comply ()
Generated Narrative: Observation Resource Observation "2d628dc2-0b9e-9494-55b3-2621e50938c5" instantiates: See on this page: ObservationDefinition/fc07b5d5-9fe1-91c2-2d06-47cb5b295e72 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "f0a04328-905c-4ec5-372e-4d6cfef18629" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "5e5a5e67-7fc6-0064-1be9-5d9d14d887e5" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not comply ()
Generated Narrative: Observation Resource Observation "cfde6776-673c-72e2-68c4-07b77cd85b74" instantiates: See on this page: ObservationDefinition/3b0e878e-4bc9-8864-862f-e28b21233e8d status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "9c56948a-1a39-6609-1c01-4d197ea57a33" instantiates: See on this page: ObservationDefinition/39ffd548-bb3d-43b9-9ca9-83f26631712b status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 103 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "1e20aed7-7626-1664-8d96-235f860d9a2c" instantiates: See on this page: ObservationDefinition/39ffd548-bb3d-43b9-9ca9-83f26631712b status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 102 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "ec6d7e30-4d70-491b-0669-a613eedd3c60" instantiates: See on this page: ObservationDefinition/39ffd548-bb3d-43b9-9ca9-83f26631712b status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 101 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "be016630-8754-7414-9014-21e020ad66c6" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 3 ()
Generated Narrative: Observation Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.1 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Individual unspecified degradation products ()
Generated Narrative: Observation Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.6 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.7 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78" instantiates: See on this page: ObservationDefinition/8bdea820-4197-7c7d-0990-7be06bf78aaf status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.6 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total degradation products ()
Generated Narrative: Observation Resource Observation "7316e094-2094-5710-4f11-75d3effc995e" instantiates: See on this page: ObservationDefinition/8f5d8abf-2cf4-8617-1e41-a74d90210dcc status: final code: Dissolution (Example Local Codes - Drug#Dissolution) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "1cedf9c1-8e89-5dbb-0e1f-0363a9ca4893" instantiates: See on this page: ObservationDefinition/8f5d8abf-2cf4-8617-1e41-a74d90210dcc status: final code: Dissolution (Example Local Codes - Drug#Dissolution) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "c350f0b1-9495-0165-2555-83ebd79da682" instantiates: See on this page: ObservationDefinition/8f5d8abf-2cf4-8617-1e41-a74d90210dcc status: final code: Dissolution (Example Local Codes - Drug#Dissolution) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "4b97e406-3fb0-9f65-0979-910ea1b9254f" instantiates: See on this page: ObservationDefinition/33a9d578-6e6b-7606-72bc-6775d36c1930 status: final code: Dissolution Quantity (Example Local Codes - Drug#Dissolution Quantity) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 90 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "bbfc28df-49bc-986c-1a0e-75e3160268b9" instantiates: See on this page: ObservationDefinition/33a9d578-6e6b-7606-72bc-6775d36c1930 status: final code: Dissolution Quantity (Example Local Codes - Drug#Dissolution Quantity) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 92 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "d6955449-16b4-107f-851d-2f99d0b47b96" instantiates: See on this page: ObservationDefinition/33a9d578-6e6b-7606-72bc-6775d36c1930 status: final code: Dissolution Quantity (Example Local Codes - Drug#Dissolution Quantity) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 95 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "591f5d75-1b2f-299b-6885-f325e4228bda" instantiates: See on this page: ObservationDefinition/ef17cff1-6586-a4a4-9168-2602140548d7 status: final code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "1dd8e506-08cf-8a15-8cd0-7c7cf1d88731" instantiates: See on this page: ObservationDefinition/ef17cff1-6586-a4a4-9168-2602140548d7 status: final code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "ae0676b9-8ce4-7c72-135e-1fa9ea7f42c3" instantiates: See on this page: ObservationDefinition/ef17cff1-6586-a4a4-9168-2602140548d7 status: final code: uniformity of dosage units (by weight) (Example Local Codes - Drug#uniformity-dosage) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "d136c4f5-62da-81eb-4fc8-144f9182589e" instantiates: See on this page: ObservationDefinition/d999ee06-6595-762c-1bda-0818ab1c6c0e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "3ab5e4eb-673b-0e66-3d2c-86d64ced0e86" instantiates: See on this page: ObservationDefinition/d999ee06-6595-762c-1bda-0818ab1c6c0e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "cec7ce65-57d7-a654-9ad6-21d162186eb9" instantiates: See on this page: ObservationDefinition/d999ee06-6595-762c-1bda-0818ab1c6c0e status: final code: Microbiological Quality (Example Local Codes - Drug#Microbiological Quality) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "66c2f585-678e-78b8-2235-1a3b37bd6e46" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "f8232d25-023d-679f-9c58-a6dc234b7a28" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "368b82be-75dd-1d97-3dbc-a7eed9869daa" instantiates: See on this page: ObservationDefinition/31e29d22-5fcb-546e-24fd-52a4a4004467 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.5 % w/w (Details: UCUM code % = '%')
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/6eb94d34-48b4-5bb0-4c05-e183d2ea3e95
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "6eb94d34-48b4-5bb0-4c05-e183d2ea3e95" manufacturer: See on this page: Organization/23dbbd32-2962-9fc3-40b1-67e864f21cd2 Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "23dbbd32-2962-9fc3-40b1-67e864f21cd2" 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: Organization Resource Organization "378fbe5f-5926-3a5c-4c64-5428df877b08" identifier: urn:oid:2.16.840.1.113883.4.82/3007270600 active: true type: Analytical Testing - Release (Pharmaceutical Organization Type Codes#analytical-testing-release) name: Testing Lab
Generated Narrative: PlanDefinition Resource PlanDefinition "246e9583-6253-6cc7-9c12-3b624f3308c1" Profile: PlanDefinition - Drug PQ Extension - History of Process PQ: Process has no history recorded yet url: http://example-server.com/fhir/PlanDefinition/246e9583-6253-6cc7-9c12-3b624f3308c1 title: Process 1.0 type: Manufacturing Process (Pharmaceutical Plan Type Codes#1244566) status: active subject: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5