Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd Profile: eCTD Substance Control of Materials identifier: materials1 status: Final type: m3.2.s.2.3 control of materials date: 2023-12-05 01:34:39+0000 author: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 title: Control of Materials Example
m3.2.s.3.1 elucidation of structure and other characteristics
Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a Profile: Drug Substance Handle identifier: salicylate classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * R16CO5Y76E name name: ACETYLSALICYLIC ACID type: Generic Name name name: ASPIRIN type: GSRS Preferred Term preferred: true
Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5 Profile: Basic Organization identifier: DUNS/143265222, FEI/6981397 name: Vidinaid Contacts - Address * Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA
Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049 Profile: Basic Organization identifier: DUNS/173265332 name: Mega Chem Supply Contacts - Address * Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
Mega Chem Supply, 350 W Main Street, Rochester, NY, United States
Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703 Profile: Excipient Drug Substance identifier: carrageenan classification: Structurally Diverse Substance grade: Company Standard manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * 5C69YCD2YJ Names - Name Type Preferred * Carrageenan GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant palmaria palmata whole United States of America
Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a Profile: Excipient Drug Substance identifier: Citric acid classification: Chemical grade: Company Standard manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * XF417D3PSL Names - Name Type Preferred * ANHYDROUS CITRIC ACID GSRS Preferred Term true SourceMaterials - Type * Chemical
Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd Profile: Excipient Drug Substance identifier: water classification: Chemical grade: BP manufacturer: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 supplier: Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000 Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical
Id: ab241f8c-d21e-4382-a70a-52190dbdf07e Version: 1.0 RawCitricacid Title: Raw Material (Carrageenan) Specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703 Date: 2023-11-28 Actions: Single Stage Identification: Then: Identification A: Identification B: Identification C: Identification D: Single Stage Microbial Limits: Then: Total Bacterial Count: Salmonella: Escherichia Coli: Single Stage Elemental Impurities: Then: Cadmium (Cd): Mercury (Hg): Arsenic (As): Lead (Pb): Single Stage Residual Solvents: Single Stage Impurity: Insoluble Matter: Single Stage Solubility in H2O:
Raw Material (Carrageenan) Specification Example
Raw Materials/Excipients/Intermediates/Reagents
Id: a2cba634-a481-4b07-9bd4-62c7ada31e1b Version: 1.0 CitricAcidSpecification Title: Citric acid specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a Date: 2023-12-01 Actions: Single Stage Appearance: Single Stage Identification: Single Stage [pH]: Single Stage Residue on Ignition:
IR spectrum conforms to reference standard
Id: 5819b223-d3d2-419f-b617-b3a9a3625b89 Version: 1.0 WaterSpecification Title: Water Specification Example Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C133931 display: Raw Materials/Excipients/Intermediates/Reagents Subject: reference: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd Date: 2023-12-01 Actions: Single Stage Color degree: Single Stage Turbidity: Single Stage Smell and taste: Single Stage Total hardness:
Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519 Profile: Basic Organization identifier: DUNS/143265625 name: J. Jones Research Contacts - Address * J. Jones Research, 123 Broad Way, New York, NY, United States
J. Jones Research, 123 Broad Way, New York, NY, United States