Generated Narrative: DiagnosticReport Resource DiagnosticReport "studyResultsReport" Triggered by: See on this page: PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b 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/PLO555 status: final code: Stability Study Report (Pharmaceutical Report Type Codes#Stability Study Report) effective: 2019-09-08 performer: See on this page: Organization/6049d921-9935-90b7-4efc-894a66483c00 result: See on this page: Observation/588a6787-0454-55ef-0b8a-4c8941b6976c See on this page: Observation/930c7f69-2546-7148-2069-b3be3a755edf See on this page: Observation/8070745c-30c4-a52e-41fd-600a913578d4 See on this page: Observation/f16113fe-27e7-0aa2-6787-9415f5051900 See on this page: Observation/1b25eb25-9149-02f6-9676-c87f90c64904 See on this page: Observation/004ed877-7729-834e-3b6b-a2cf4bdb2377 See on this page: Observation/f958e1e9-6023-4e39-2ffe-a9c8f135a2dd conclusion: The samples have been assessed and the conclusion is...
information about statistical model utilized to interpret stability study results
The samples have been assessed and the conclusion is...
Generated Narrative: PlanDefinition Resource PlanDefinition "c3973835-10ca-0796-0a26-aa8afafc9c5b" url: http://example-server.com/fhir/PlanDefinition/c3973835-10ca-0796-0a26-aa8afafc9c5b title: Stability Monitoring Program type: Stability Study Protocol (Pharmaceutical Plan Type Codes#1244588) status: active subject: See on this page: SubstanceDefinition/2e3a85b5-790a-a108-3627-edf0ec6f1210 description: Description of the study study plan which includes tests, time points, storage conditions, method action title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol action title: Long-Term description: 30°C/65% RH action action action action action action action action action title: Accelerated description: 40°C/75% RH action action action action action action action action
Description of the study study plan which includes tests, time points, storage conditions, method
Stability Test Protocol for Long-term and Accelerated Storage of Stelbatolol
Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "643d8b44-71f4-2b58-07e8-51c22b294b25" url: http://example-server.com/fhir/SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25 status: active typeTested preference: preferred Handlings - Instruction * 30°C/65% RH
Generated Narrative: ActivityDefinition Resource ActivityDefinition "10d7b693-7a0e-2f71-9a10-642e5a0a5d42" url: http://example-server.com/fhir/ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 title: Long-term - 30°C/65% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba, http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e
Generated Narrative: ActivityDefinition Resource ActivityDefinition "480a61f8-14b3-233e-8e5f-7f0db9696a1e" url: http://example-server.com/fhir/ActivityDefinition/480a61f8-14b3-233e-8e5f-7f0db9696a1e title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "bee486c4-6ab5-6293-4114-d4be24f303d3" url: http://example-server.com/fhir/ActivityDefinition/bee486c4-6ab5-6293-4114-d4be24f303d3 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "99893d3c-520c-8d7b-6d73-f46b1a662201" url: http://example-server.com/fhir/ActivityDefinition/99893d3c-520c-8d7b-6d73-f46b1a662201 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "b3254b8e-6fc3-88d3-7d38-0afcf13c4f67" url: http://example-server.com/fhir/ActivityDefinition/b3254b8e-6fc3-88d3-7d38-0afcf13c4f67 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "c9b53a46-2f61-7b3f-5780-5f5c79a47f12" url: http://example-server.com/fhir/ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "d6f7de9d-57a5-6a2c-1c2f-0d65718860f2" url: http://example-server.com/fhir/ActivityDefinition/d6f7de9d-57a5-6a2c-1c2f-0d65718860f2 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ActivityDefinition Resource ActivityDefinition "75073965-82eb-407d-34cf-3a7767a38149" url: http://example-server.com/fhir/ActivityDefinition/75073965-82eb-407d-34cf-3a7767a38149 title: Long-term - 30°C/65% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba
Generated Narrative: ObservationDefinition Resource ObservationDefinition "18762cff-9e29-6e71-1184-e9202fee8cba" url: http://example-server.com/fhir/ObservationDefinition/18762cff-9e29-6e71-1184-e9202fee8cba title: X status: active code: Battery of tests 'X' at 30°C/65% RH () specimen: See on this page: SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25 hasMember: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e
Generated Narrative: ObservationDefinition Resource ObservationDefinition "559ffdc3-349b-a4a3-a651-ce2715f08d69" url: http://example-server.com/fhir/ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 title: Description status: active code: Description (Example Local Codes - Drug#DESC) QualifiedValues - Extension *
Generated Narrative: ObservationDefinition Resource ObservationDefinition "7943795a-2abe-666f-545f-133e23b97119" url: http://example-server.com/fhir/ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 title: Assay (% w/w) (Mean) status: active code: Assay (% w/w) (Mean) (Example Local Codes - Drug#ASSAY "Assay") QualifiedValues - Range * 98-102 % w/w
Generated Narrative: ObservationDefinition Resource ObservationDefinition "73d9d304-a0b8-31b6-1165-346563b9305e" url: http://example-server.com/fhir/ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e title: Drug-related Impurities Content by LC (% w/w) status: active code: Impurities (Example Local Codes - Drug#Impurities) qualifiedValue appliesTo: Impurity () range: ?-0.5 qualifiedValue appliesTo: Impurity 2 () range: ?-0.52 qualifiedValue appliesTo: Any Unspecified Impurity () range: ?-0.10 qualifiedValue appliesTo: Total Impurities () range: ?-2.0 Components - Code * Impurity (Example Local Codes - Drug#IMP)
Drug-related Impurities Content by LC (% w/w)
Generated Narrative: ObservationDefinition Resource ObservationDefinition "31abea79-81da-17f8-9d8c-94e9bb75876e" url: http://example-server.com/fhir/ObservationDefinition/31abea79-81da-17f8-9d8c-94e9bb75876e title: Y status: active code: Battery of tests 'Y' at 30°C/65% RH () specimen: See on this page: SpecimenDefinition/643d8b44-71f4-2b58-07e8-51c22b294b25 hasMember: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
Generated Narrative: ObservationDefinition Resource ObservationDefinition "6b96124b-1a44-0b6b-6783-d6c49360230b" url: http://example-server.com/fhir/ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b title: Identification status: active code: Identification (Example Local Codes - Drug#IDT) QualifiedValues - Extension *
Generated Narrative: SpecimenDefinition Resource SpecimenDefinition "306637ec-1041-80e8-8e77-e7ca814253e1" url: http://example-server.com/fhir/SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1 status: active typeTested preference: preferred Handlings - Instruction * 40°C/75% RH
Generated Narrative: ActivityDefinition Resource ActivityDefinition "1b43a536-3c29-3427-0b93-e35866ef8495" url: http://example-server.com/fhir/ActivityDefinition/1b43a536-3c29-3427-0b93-e35866ef8495 title: Accelerated - 40°C/70% RH - XY status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc, http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6
Generated Narrative: ActivityDefinition Resource ActivityDefinition "8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9" url: http://example-server.com/fhir/ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9 title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc
Generated Narrative: ActivityDefinition Resource ActivityDefinition "cf2f00df-971f-0bab-8768-4251b1ad0817" url: http://example-server.com/fhir/ActivityDefinition/cf2f00df-971f-0bab-8768-4251b1ad0817 title: Accelerated - 40°C/70% RH - X status: active observationRequirement: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc
Generated Narrative: ObservationDefinition Resource ObservationDefinition "35fa7b97-98d3-35d3-5672-4ab1047d57fc" url: http://example-server.com/fhir/ObservationDefinition/35fa7b97-98d3-35d3-5672-4ab1047d57fc title: X status: active code: Battery of tests 'X' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1 hasMember: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119
Generated Narrative: ObservationDefinition Resource ObservationDefinition "accb8802-4223-61e2-8c79-2282e22a2bb6" url: http://example-server.com/fhir/ObservationDefinition/accb8802-4223-61e2-8c79-2282e22a2bb6 title: Y status: active code: Battery of tests 'Y' at 40°C/75% RH () specimen: See on this page: SpecimenDefinition/306637ec-1041-80e8-8e77-e7ca814253e1 hasMember: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b
Generated Narrative: Specimen Resource Specimen "6a5354bf-602c-99f1-324b-0bb5f7e06cd5" Collections - Collected[x] * 2020-06 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Observation Resource Observation "588a6787-0454-55ef-0b8a-4c8941b6976c" Triggered by: See on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/6a5354bf-602c-99f1-324b-0bb5f7e06cd5 hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.15 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 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 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 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 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.05 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 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 % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-initial-1-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-initial-1-Impurity1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: 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 () Generated Narrative: Observation #LongTerm30C-initial-1-Impurity2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: 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 #LongTerm30C-initial-1-ImpurityUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.05 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-initial-1-ImpurityTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.8 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-initial-1-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.15 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-initial-1-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Test Components - Long-term 25C etc - Initial (XYZ)
Generated Narrative: Specimen Resource Specimen "3b550915-4467-83d3-340f-9bd6d2857191" Collections - Collected[x] * 2020-06 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Observation Resource Observation "930c7f69-2546-7148-2069-b3be3a755edf" Triggered by: See on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/3b550915-4467-83d3-340f-9bd6d2857191 hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.152 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.12 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.22 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.052 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.82 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d 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 #LongTerm30C-initial-2-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.12 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-imp2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.22 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.052 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-initial-2-Degradation-impTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.82 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-initial-2-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.152 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-initial-2-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not comply ()
Generated Narrative: Specimen Resource Specimen "b1726ce3-8bb5-403e-2e9b-f5d79cc716f9" Collections - Collected[x] * 2020-06 processing description: No storage processing description: 25°C/60% RH
Generated Narrative: Observation Resource Observation "8070745c-30c4-a52e-41fd-600a913578d4" Triggered by: See on this page: ActivityDefinition/10d7b693-7a0e-2f71-9a10-642e5a0a5d42 status: final code: Test Components - Long-term 25C etc - Initial (XYZ) () subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/b1726ce3-8bb5-403e-2e9b-f5d79cc716f9 hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.152 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.12 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.22 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.052 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.82 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd 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 #LongTerm30C-initial-3-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.12 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-imp2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.22 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.052 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-initial-3-Degradation-impTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.82 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-initial-3-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.152 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-initial-3-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Does not comply ()
Generated Narrative: Specimen Resource Specimen "7aa5fdea-17d7-29f1-1ed4-5c05eb62285a" Collections - Collected[x] * 2020-06 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 30°C/65% RH
Generated Narrative: Specimen Resource Specimen "872a645f-120e-44c0-62c0-9be05acf543b" Collections - Collected[x] * 2020-06 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 30°C/65% RH
Generated Narrative: Specimen Resource Specimen "7c06a03c-9cf7-2e1b-a236-d60038f1439b" Collections - Collected[x] * 2020-06 processing description: Store for 18 months time: 2020-12 --> 2022-06 processing description: 30°C/65% RH
Generated Narrative: Observation Resource Observation "f16113fe-27e7-0aa2-6787-9415f5051900" Triggered by: See on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 status: final code: Long-term - 30°C/65% RH - 18 months (X) () subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/7aa5fdea-17d7-29f1-1ed4-5c05eb62285a hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 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/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-1-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-1-Impurity1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-1-Impurity2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-18m-1-ImpurityTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-18m-1-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-18m-1-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "1b25eb25-9149-02f6-9676-c87f90c64904" Triggered by: See on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 status: final code: Long-term - 30°C/65% RH - 18 months (X) () subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/872a645f-120e-44c0-62c0-9be05acf543b hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 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/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-2-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-2-Impurity1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-2-Impurity2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-18m-2-ImpurityTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-18m-2-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-18m-2-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/cbcecab6-374c-396f-29be-877da7285e8d effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Observation Resource Observation "004ed877-7729-834e-3b6b-a2cf4bdb2377" Triggered by: See on this page: ActivityDefinition/c9b53a46-2f61-7b3f-5780-5f5c79a47f12 status: final code: Long-term - 30°C/65% RH - 18 months (X) () subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/7c06a03c-9cf7-2e1b-a236-d60038f1439b hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 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/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-3-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #LongTerm30C-18m-3-Impurity1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #LongTerm30C-18m-3-Impurity2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.218 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0518 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #LongTerm30C-18m-3-ImpurityTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.818 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #LongTerm30C-18m-3-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.118 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #LongTerm30C-18m-3-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Generated Narrative: Specimen Resource Specimen "b04c9321-069c-4da8-8ed0-86337ea22c30" Collections - Collected[x] * 2020-06 processing description: No storage processing description: 40°C/75% RH
Generated Narrative: Observation Resource Observation "f958e1e9-6023-4e39-2ffe-a9c8f135a2dd" Triggered by: See on this page: ActivityDefinition/8a453cd8-1ac3-4c86-48c3-3e5ea9ee76a9 status: final code: Accelerated - 40°C/67% RH - 3 months (X) () subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 specimen: See on this page: Specimen/b04c9321-069c-4da8-8ed0-86337ea22c30 hasMember: instantiates: See on this page: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Doesn't comply () instantiates: See on this page: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.113 % w/w (Details: UCUM code % = '%') instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.113 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.213 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0513 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () instantiates: See on this page: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.813 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () instantiates: See on this page: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: See on this page: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies () Generated Narrative: Observation #Accelerated40C-3m-1-Description instantiates: ObservationDefinition/559ffdc3-349b-a4a3-a651-ce2715f08d69 status: final code: Description (Example Local Codes - Drug#DESC) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Doesn't comply () Generated Narrative: Observation #Accelerated40C-3m-1-Impurity1 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.113 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity () Generated Narrative: Observation #Accelerated40C-3m-1-Impurity2 instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.213 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Impurity 2 () Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityUnspecified instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/a3fdc23b-6c16-2e65-481e-3fc895b37b87 effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: <0.0513 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Any Unspecified Impurity () Generated Narrative: Observation #Accelerated40C-3m-1-ImpurityTotal instantiates: ObservationDefinition/73d9d304-a0b8-31b6-1165-346563b9305e status: final code: Impurities (Example Local Codes - Drug#Impurities) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.813 % w/w (Details: UCUM code % = '%') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Total Impurities () Generated Narrative: Observation #Accelerated40C-3m-1-Assay instantiates: ObservationDefinition/7943795a-2abe-666f-545f-133e23b97119 status: final code: Assay (Example Local Codes - Drug#ASSAY) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: 0.113 % w/w (Details: UCUM code % = '%') Generated Narrative: Observation #Accelerated40C-3m-1-Identification instantiates: ObservationDefinition/6b96124b-1a44-0b6b-6783-d6c49360230b status: final code: Identification (Example Local Codes - Drug#IDT) subject: Substance/ae1f3b4c-4f14-1460-6903-7260959ea2cd effective: 2023-01-01 12:00:00+0000 performer: Organization/378fbe5f-5926-3a5c-4c64-5428df877b08 value: Complies ()
Accelerated - 40°C/67% RH - 3 months (X)
Generated Narrative: Organization Resource Organization "62c1b1b4-8d15-26d2-57f9-25a2f60b6181" 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 "6049d921-9935-90b7-4efc-894a66483c00" 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: SubstanceDefinition Resource SubstanceDefinition "2e3a85b5-790a-a108-3627-edf0ec6f1210" identifier: http://example.company.org/companySubstanceIdentifier/4444455555 manufacturer: See on this page: Organization/62c1b1b4-8d15-26d2-57f9-25a2f60b6181 Names - Name * Stelbatolol
Generated Narrative: Organization Resource Organization "e2359a4e-3091-23f8-2242-87e701830d55" 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 - Stability (Pharmaceutical Organization Type Codes#analytical-testing-stability) name: Testing Lab
Generated Narrative: Substance Resource Substance "a3fdc23b-6c16-2e65-481e-3fc895b37b87" Medication Manufacturing Batch url manufacturingDate value: 2020-01 url batchQuantity value: 120 kg url batchUtilization value: Production (NCI Thesaurus#C133990 "Commercial") url assignedManufacturer value: See on this page: Organization/e2359a4e-3091-23f8-2242-87e701830d55 url container 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/2e3a85b5-790a-a108-3627-edf0ec6f1210
Generated Narrative: Substance Resource Substance "cbcecab6-374c-396f-29be-877da7285e8d" 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/e2359a4e-3091-23f8-2242-87e701830d55 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/2e3a85b5-790a-a108-3627-edf0ec6f1210
Generated Narrative: Substance Resource Substance "ae1f3b4c-4f14-1460-6903-7260959ea2cd" 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/e2359a4e-3091-23f8-2242-87e701830d55 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/2e3a85b5-790a-a108-3627-edf0ec6f1210