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: S.4.4 BATCH ANALYSIS type: Specification Protocol (Pharmaceutical Plan Type Codes#1244577) status: active subject: See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130 description: Narrative description of analysis action title: Batch Specification for Drug Substance code: Overall set of actions () Actions - Code Definition[x] * Test () http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f * Test () http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 * Test () http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 * Test () http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 * Test () http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b * Test () http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 * Test () http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 * Test () http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 * Test () http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4
Generated Narrative: ObservationDefinition Resource ObservationDefinition "13033a89-927a-10e0-503e-5f901bdca30f" url: http://example-server.com/fhir/ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f title: Description status: active code: Description (Example Local Codes - Drug#DESC) method: Visual inspection () QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "8395ae1d-5064-0ab7-a297-6b20285b2230" url: http://example-server.com/fhir/ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) method: Identification by IR spectroscopy Identification by HPLC () QualifiedValues - Extension *
Identification by IR spectroscopy Identification by HPLC
Generated Narrative: ObservationDefinition Resource ObservationDefinition "2117208e-4185-9091-1f86-cce37b121838" url: http://example-server.com/fhir/ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 title: Assay status: active code: Assay (Example Local Codes - Drug#ASSAY) method: Assay by LC () QualifiedValues - Range * 98-102 % w/w
Generated Narrative: ObservationDefinition Resource ObservationDefinition "d04e0f2a-6ee7-6c2e-1db8-7df394c927b8" url: http://example-server.com/fhir/ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 title: Drug Substance Related Organic impurities status: active code: Drug Substance Related Organic impurities (Example Local Codes - Drug#DGP-s) method: Organic impurities by LC () qualifiedValue appliesTo: Impurity 1 () range: ?-0.5 qualifiedValue appliesTo: Impurity 2 () range: ?-0.5 qualifiedValue appliesTo: Impurity 3 () range: ?-0.5 qualifiedValue appliesTo: Any individual unspecified impurity () range: ?-0.10 qualifiedValue appliesTo: Total impurities () range: ?-2.0 Components - Code * Impurity (Example Local Codes - Drug#IMP)
Drug Substance Related Organic impurities
Impurity 3 was included in the release specification throughout clinical development, and no longer forms a part of a commercial release specification; see Section S.4.5 Justification of Specification and Section S.2.5 Validation (PPQ) for additional data
Generated Narrative: ObservationDefinition Resource ObservationDefinition "0634020c-8729-99fc-7637-89799d7c445b" url: http://example-server.com/fhir/ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b title: Mutagenic impurities status: active code: Mutagenic impurities (Example Local Codes - Drug#MUT) method: Impurity 5 content by LC-MS () QualifiedValues - AppliesTo Range * Impurity - Mutagenic () ?-50 Components - Code * Impurity (Example Local Codes - Drug#IMP)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "4e67725b-20c8-158e-9d53-1810bfa58d87" url: http://example-server.com/fhir/ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 title: Enantiomeric purity status: active code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) method: Enantiomeric purity by LC () QualifiedValues - Range * 99.6-? %
Generated Narrative: ObservationDefinition Resource ObservationDefinition "2daba8ca-211f-4f4b-4028-16c30fe22ee8" url: http://example-server.com/fhir/ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 title: Residual solvents status: active code: Residual solvents (Example Local Codes - Drug#SOL) method: Residual solvents by headspace GC () qualifiedValue appliesTo: Solvent 1 () range: ?-0.1 qualifiedValue appliesTo: Solvent 2 () range: ?-2.0 Components - Code * Solvent (Example Local Codes - Drug#SOLV)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "17b322fe-53ea-6c1f-521b-3b148ac05eb4" url: http://example-server.com/fhir/ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 title: Water Content status: active code: Water Content (Example Local Codes - Drug#WaterContent) method: USP Karl Fischer titration () QualifiedValues - Range * ?-1.0
Generated Narrative: ObservationDefinition Resource ObservationDefinition "11fcfe6b-7498-132b-2def-efae51b302d4" url: http://example-server.com/fhir/ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 title: Particle size distribution status: active code: Particle size distribution (Example Local Codes - Drug#PART) method: Laser diffraction () qualifiedValue appliesTo: D(v,0.9) () range: ?-319 qualifiedValue appliesTo: D(v,0.5) () range: ?-145 qualifiedValue appliesTo: D(v,0.1) () range: ?-20 Components - Code * Particle size (Example Local Codes - Drug#PARTS)
Particle Size Distribution was included in the release specification throughout clinical development, and no longer forms a part of the commercial release specification; See Section S.4.5 Justification of Specification for data and rationale.
Generated Narrative: Substance Resource Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1" Medication Manufacturing Batch url batchQuantity value: 120 kg url manufacturingDate value: 2020-01 url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Extension - Batch Release Date PQ: 2019-09-08 Extension - Batch Retest Date PQ: 2022-09-08 Extension - Manufacturing Process PQ: See on this page: PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975 Extension - Actual Yield PQ: 4.8 kg identifier: CAT1 instance: true Codes - Reference * See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
Generated Narrative: Substance Resource Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4" Medication Manufacturing Batch url manufacturingDate value: 2020-02 url batchQuantity value: 120 kg url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 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/8dae93e0-048d-35a4-71ea-7c603184a130
Generated Narrative: Substance Resource Substance "ef17cff1-6586-a4a4-9168-2602140548d7" Medication Manufacturing Batch url manufacturingDate value: 2020-03 url batchQuantity value: 120 kg url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 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/8dae93e0-048d-35a4-71ea-7c603184a130
Generated Narrative: PlanDefinition Resource PlanDefinition "b30a1024-37db-a1bc-05e5-cc4596d92975" url: http://example-server.com/fhir/PlanDefinition/b30a1024-37db-a1bc-05e5-cc4596d92975 title: Process 1.1 type: Manufacturing Process (Pharmaceutical Plan Type Codes#1244566) status: active subject: See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "8dae93e0-048d-35a4-71ea-7c603184a130" manufacturer: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330 Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "3d399cbc-244e-9b5f-838b-b7daa0489330" 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: 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/81f552f9-8458-3cf4-8379-eea5417a9de2 See on this page: Observation/50bf6f69-a3f5-678b-469b-c5df5cca4c86 See on this page: Observation/145fd3b7-3678-867f-4298-a6c781b86de3 See on this page: Observation/55c89944-60d1-4eea-a2c3-6c53e3622bc5 See on this page: Observation/adb51ab6-00a9-1078-69e5-d32c025a857c See on this page: Observation/916a0ae2-9c43-72f0-a22a-c5f8ce902125 See on this page: Observation/6deb4306-1193-24ae-a565-f73225652bdd See on this page: Observation/f6aabd2f-5902-57e7-6126-eccd9158a5b5 See on this page: Observation/32f598e4-a0e0-98dc-41dd-0f8397f953ad See on this page: Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d See on this page: Observation/d3e572b7-14fd-744b-4123-58741d75571e See on this page: Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8 See on this page: Observation/da92c71f-a12a-1980-11a3-80e3d1852244 See on this page: Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6 See on this page: Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487 See on this page: Observation/732237a9-4b3b-27cc-99ca-6b913e622a29 See on this page: Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec See on this page: Observation/7fc395b1-59e4-78be-0512-cf92133c0fac See on this page: Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572 See on this page: Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2 See on this page: Observation/0244eafe-3126-909b-7d8d-4253f45f525c See on this page: Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c See on this page: Observation/84f015ac-9572-324f-8013-0b999cc95bbd See on this page: Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e See on this page: Observation/02d9e6be-833c-1c6d-a64a-baa3935c959d See on this page: Observation/d3e572b7-14fd-744b-4123-58741d75571e See on this page: Observation/fe6ca484-a755-9a0b-a074-b6ee0a907ff8 See on this page: Observation/da92c71f-a12a-1980-11a3-80e3d1852244 See on this page: Observation/8bf75da1-9221-66fe-6725-c64cb45a57e6 See on this page: Observation/31bfeff4-4a7d-3be5-878e-fb674d3d5487 See on this page: Observation/732237a9-4b3b-27cc-99ca-6b913e622a29 See on this page: Observation/52afbeb4-4958-a275-a0ca-d70b2b5240ec See on this page: Observation/7fc395b1-59e4-78be-0512-cf92133c0fac See on this page: Observation/9c98bd8a-7dda-2f01-0dbd-8c60b60e8572 See on this page: Observation/97b16ff8-8e0f-915a-9d65-7fab108f40c2 See on this page: Observation/0244eafe-3126-909b-7d8d-4253f45f525c See on this page: Observation/10b80cbd-45d3-9be1-63b9-29f04b47376c See on this page: Observation/84f015ac-9572-324f-8013-0b999cc95bbd See on this page: Observation/987daeaa-4c2a-72b7-780f-4a9403163a3e See on this page: Observation/ff26533d-88a8-7f18-a275-42dc1373a388 See on this page: Observation/c99666d2-7962-9a71-58f6-7b2e5aa662f5 See on this page: Observation/c18e21d3-7113-4d08-4ff3-0c9718596f64 See on this page: Observation/66fdac46-2a6b-a66f-891b-8dcf67cc46c7 See on this page: Observation/8306cfc5-158f-1a53-a683-048b226060d9 See on this page: Observation/fc49ad55-07d1-997d-6695-bbff44746e75 See on this page: Observation/f8160692-a7a8-3fa6-9f35-e7df35f51ac0 See on this page: Observation/a531aee9-4c21-06af-352c-a3615b5d957e See on this page: Observation/033ce81d-5f0d-7a3e-93d3-fc64e122a1fd See on this page: Observation/ba8a182e-8571-6cbd-047b-612735d599d2 See on this page: Observation/0b5b94cc-7a1a-4ada-66c7-954ceb528d67 See on this page: Observation/6afaacee-11a6-58b2-47df-5f79722c66ac See on this page: Observation/c2644a86-1684-286e-00e2-dcaf907a8970 See on this page: Observation/cb5f6872-6eeb-727a-7c33-f2c438581a1c See on this page: Observation/7faaf980-7c10-7b9a-9572-1bacd485824e See on this page: Observation/e4d2118a-8562-9eb1-2c14-4e145d2a95fc See on this page: Observation/ec078717-9512-4db4-77c6-2c7e29d213a6 See on this page: Observation/05cfb495-2580-561a-688d-ce6ea24c8962 See on this page: Observation/d2a60ae5-96b4-3d13-38da-729c652347a3 See on this page: Observation/c3f51325-2f5f-194c-919b-2219ee1f5c45 See on this page: Observation/e9d89693-11b1-13ed-5cde-606fc1b8372c See on this page: Observation/2659b000-96e2-1b8b-129b-0c00e1074b0f See on this page: Observation/10b47328-36fa-343d-5699-5b32b30a6d33 See on this page: Observation/e6780766-317a-382f-92d2-79825f506cc5 conclusion: The samples have been assessed and the conclusion is...
The samples have been assessed and the conclusion is...
Generated Narrative: Observation Resource Observation "81f552f9-8458-3cf4-8379-eea5417a9de2" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
Generated Narrative: Observation Resource Observation "50bf6f69-a3f5-678b-469b-c5df5cca4c86" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
Generated Narrative: Observation Resource Observation "145fd3b7-3678-867f-4298-a6c781b86de3" instantiates: See on this page: ObservationDefinition/13033a89-927a-10e0-503e-5f901bdca30f status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Pass ()
Generated Narrative: Observation Resource Observation "55c89944-60d1-4eea-a2c3-6c53e3622bc5" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms ()
Generated Narrative: Observation Resource Observation "adb51ab6-00a9-1078-69e5-d32c025a857c" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not conform ()
Generated Narrative: Observation Resource Observation "916a0ae2-9c43-72f0-a22a-c5f8ce902125" instantiates: See on this page: ObservationDefinition/8395ae1d-5064-0ab7-a297-6b20285b2230 status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Conforms ()
Generated Narrative: Observation Resource Observation "6deb4306-1193-24ae-a565-f73225652bdd" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 94 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
Generated Narrative: Observation Resource Observation "f6aabd2f-5902-57e7-6126-eccd9158a5b5" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 95 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
Generated Narrative: Observation Resource Observation "32f598e4-a0e0-98dc-41dd-0f8397f953ad" instantiates: See on this page: ObservationDefinition/2117208e-4185-9091-1f86-cce37b121838 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 96 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
Generated Narrative: Observation Resource Observation "02d9e6be-833c-1c6d-a64a-baa3935c959d" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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 % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "d3e572b7-14fd-744b-4123-58741d75571e" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 1 ()
Generated Narrative: Observation Resource Observation "fe6ca484-a755-9a0b-a074-b6ee0a907ff8" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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 "da92c71f-a12a-1980-11a3-80e3d1852244" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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 % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "8bf75da1-9221-66fe-6725-c64cb45a57e6" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 ()
Generated Narrative: Observation Resource Observation "31bfeff4-4a7d-3be5-878e-fb674d3d5487" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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 "732237a9-4b3b-27cc-99ca-6b913e622a29" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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 3 ()
Generated Narrative: Observation Resource Observation "52afbeb4-4958-a275-a0ca-d70b2b5240ec" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 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 3 ()
Generated Narrative: Observation Resource Observation "7fc395b1-59e4-78be-0512-cf92133c0fac" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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 3 ()
Generated Narrative: Observation Resource Observation "9c98bd8a-7dda-2f01-0dbd-8c60b60e8572" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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) Any individual unspecified impurity ()
Generated Narrative: Observation Resource Observation "97b16ff8-8e0f-915a-9d65-7fab108f40c2" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 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) Any individual unspecified impurity ()
Generated Narrative: Observation Resource Observation "0244eafe-3126-909b-7d8d-4253f45f525c" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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) Any individual unspecified impurity ()
Generated Narrative: Observation Resource Observation "10b80cbd-45d3-9be1-63b9-29f04b47376c" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
Generated Narrative: Observation Resource Observation "84f015ac-9572-324f-8013-0b999cc95bbd" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
Generated Narrative: Observation Resource Observation "987daeaa-4c2a-72b7-780f-4a9403163a3e" instantiates: See on this page: ObservationDefinition/d04e0f2a-6ee7-6c2e-1db8-7df394c927b8 status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.02 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total impurities ()
Generated Narrative: Observation Resource Observation "ff26533d-88a8-7f18-a275-42dc1373a388" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic impurities (Example Local Codes - Drug#MUT) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 20 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity - Mutagenic ()
Generated Narrative: Observation Resource Observation "c99666d2-7962-9a71-58f6-7b2e5aa662f5" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities") subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 22 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "c18e21d3-7113-4d08-4ff3-0c9718596f64" instantiates: See on this page: ObservationDefinition/0634020c-8729-99fc-7637-89799d7c445b status: final code: Mutagenic (Example Local Codes - Drug#MUT "Mutagenic impurities") subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 18 % (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "66fdac46-2a6b-a66f-891b-8dcf67cc46c7" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
Generated Narrative: Observation Resource Observation "8306cfc5-158f-1a53-a683-048b226060d9" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: CAT1, CAT2 and CAT3 met the clinical specification in place at time of testing; clinical specification release limit for Assay was 93% w/w; clinical specification release limit for Enantiomeric Purity was NLT 91.0%
Generated Narrative: Observation Resource Observation "fc49ad55-07d1-997d-6695-bbff44746e75" instantiates: See on this page: ObservationDefinition/4e67725b-20c8-158e-9d53-1810bfa58d87 status: final code: Enantiomeric purity (Example Local Codes - Drug#enantiomeric-purity) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 91.5 % (Details: UCUM code % = '%') note: Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.
Batch 3 did not originally meet specification criteria, and was subject to reprocessing and repurification. The updated result is presented in this table. The lot was not distributed for human use.
Generated Narrative: Observation Resource Observation "f8160692-a7a8-3fa6-9f35-e7df35f51ac0" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
Generated Narrative: Observation Resource Observation "a531aee9-4c21-06af-352c-a3615b5d957e" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 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] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
Generated Narrative: Observation Resource Observation "033ce81d-5f0d-7a3e-93d3-fc64e122a1fd" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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] * Solvent (Example Local Codes - Drug#SOLV) Solvent 1 ()
Generated Narrative: Observation Resource Observation "ba8a182e-8571-6cbd-047b-612735d599d2" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
Generated Narrative: Observation Resource Observation "0b5b94cc-7a1a-4ada-66c7-954ceb528d67" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.5 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
Generated Narrative: Observation Resource Observation "6afaacee-11a6-58b2-47df-5f79722c66ac" instantiates: See on this page: ObservationDefinition/2daba8ca-211f-4f4b-4028-16c30fe22ee8 status: final code: Residual solvents (Example Local Codes - Drug#SOL) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 1.2 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Solvent (Example Local Codes - Drug#SOLV) Solvent 2 ()
Generated Narrative: Observation Resource Observation "c2644a86-1684-286e-00e2-dcaf907a8970" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "cb5f6872-6eeb-727a-7c33-f2c438581a1c" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "7faaf980-7c10-7b9a-9572-1bacd485824e" instantiates: See on this page: ObservationDefinition/17b322fe-53ea-6c1f-521b-3b148ac05eb4 status: final code: Water Content (Example Local Codes - Drug#WaterContent) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%')
Generated Narrative: Observation Resource Observation "e4d2118a-8562-9eb1-2c14-4e145d2a95fc" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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 % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) D(v,0.9) ()
Generated Narrative: Observation Resource Observation "ec078717-9512-4db4-77c6-2c7e29d213a6" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) D(v,0.9) ()
Generated Narrative: Observation Resource Observation "05cfb495-2580-561a-688d-ce6ea24c8962" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.9) ()
Generated Narrative: Observation Resource Observation "d2a60ae5-96b4-3d13-38da-729c652347a3" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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 % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
Generated Narrative: Observation Resource Observation "c3f51325-2f5f-194c-919b-2219ee1f5c45" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.4 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
Generated Narrative: Observation Resource Observation "e9d89693-11b1-13ed-5cde-606fc1b8372c" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.5) ()
Generated Narrative: Observation Resource Observation "2659b000-96e2-1b8b-129b-0c00e1074b0f" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/87ef899b-14dd-26b7-7416-7ec1d01b62a1 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] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()
Generated Narrative: Observation Resource Observation "10b47328-36fa-343d-5699-5b32b30a6d33" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/6412c5d4-1b7d-8405-85dc-75dbaa300ea4 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] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()
Generated Narrative: Observation Resource Observation "e6780766-317a-382f-92d2-79825f506cc5" instantiates: See on this page: ObservationDefinition/11fcfe6b-7498-132b-2def-efae51b302d4 status: final code: Particle size distribution (Example Local Codes - Drug#PART) subject: See on this page: Substance/ef17cff1-6586-a4a4-9168-2602140548d7 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] * Particle Size (Example Local Codes - Drug#SIZE) D(v,0.1) ()