Generated Narrative: DiagnosticReport Resource DiagnosticReport "diagnosticreport-product-impurities" Profile: DiagnosticReport - Analysis Drug PQ identifier: https://eudract.europa.eu/example/identifier/ABC1234 status: final code: Impurities Report (Pharmaceutical Report Type Codes#Impurities Report) effective: 2020-12 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 result: See on this page: Observation/ab7997fa-7b46-1175-3f01-6f6997f7878a See on this page: Observation/4052f28b-64a2-392d-35e4-ec8e912434d2 See on this page: Observation/34ebc51d-8105-0589-3c8d-e7aa6bd0a06c See on this page: Observation/2940bf11-05bf-6ce2-3c64-457d0d1f9913 See on this page: Observation/332b1e76-6f70-2b4e-5d0c-f22a0e042d3e See on this page: Observation/f0a13a3b-2e8b-594f-6874-6050511e4c57 See on this page: Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a795 See on this page: Observation/be016630-8754-7414-9014-21e020ad66c6 See on this page: Observation/92568f68-78f3-908c-6935-ff5f3d574dd6 See on this page: Observation/7fe7ccd7-6449-0186-2282-3eeb4cf6a796 See on this page: Observation/be016630-8754-7414-9014-21e020ad66c7 See on this page: Observation/92568f68-78f3-908c-6935-ff5f3d574dd7 See on this page: Observation/a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12 See on this page: Observation/d8533dcb-03f8-5997-6ccf-4f9b6f7a5745 See on this page: Observation/7cec19a2-34a7-6b80-3d60-083b2cc64fcb See on this page: Observation/27aa47fd-7964-4f96-6495-b2bec7f160e7 See on this page: Observation/6a78bcde-4781-226c-946e-a4b6915c1899 See on this page: Observation/f9f11088-7527-947c-3d3f-e71b32e13c78 See on this page: Observation/27aa47fd-7964-4f96-6495-b2bec7f160e8 See on this page: Observation/6a78bcde-4781-226c-946e-a4b6915c1890 See on this page: Observation/f9f11088-7527-947c-3d3f-e71b32e13c79 See on this page: Observation/27aa47fd-7964-4f96-6495-b2bec7f160e9 See on this page: Observation/6a78bcde-4781-226c-946e-a4b6915c189b See on this page: Observation/f9f11088-7527-947c-3d3f-e71b32e13c70 conclusion: 1. Elemental Impurities - No elemental impurities are intentionally added during the manufacturing of drug product...
1. Elemental Impurities - No elemental impurities are intentionally added during the manufacturing of drug product...
Generated Narrative: Medication Resource Medication "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" code: () Batches - Extension LotNumber * 33445
Generated Narrative: Medication Resource Medication "a9dfda53-734b-045f-7ae4-94a6281d53bc" code: () Batches - Extension LotNumber * 33446
Generated Narrative: Medication Resource Medication "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" code: () Batches - Extension LotNumber * 33447
Generated Narrative: Organization Resource Organization "0102bca4-46c1-a6bf-1025-cd403fee710a" identifier: urn:oid:2.16.840.1.113883.4.82/3010027650 active: true type: Drug Product Manufacture (Pharmaceutical Organization Type Codes#drug-product-manufacture) name: AAA Pharmaceutical, Inc. Contacts - Address * 681 Main Street Lumberton New Jersey 08048 USA
Generated Narrative: Observation Resource Observation "ab7997fa-7b46-1175-3f01-6f6997f7878a" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <5 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Generated Narrative: Observation Resource Observation "4052f28b-64a2-392d-35e4-ec8e912434d2" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Generated Narrative: Observation Resource Observation "34ebc51d-8105-0589-3c8d-e7aa6bd0a06c" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cd (SNOMED CT#66586000 "Cadmium (substance)")
Generated Narrative: Observation Resource Observation "2940bf11-05bf-6ce2-3c64-457d0d1f9913" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Generated Narrative: Observation Resource Observation "332b1e76-6f70-2b4e-5d0c-f22a0e042d3e" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Generated Narrative: Observation Resource Observation "f0a13a3b-2e8b-594f-6874-6050511e4c57" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Pb (SNOMED CT#88488004 "Lead (substance)")
Generated Narrative: Observation Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a795" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Generated Narrative: Observation Resource Observation "be016630-8754-7414-9014-21e020ad66c6" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Generated Narrative: Observation Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd6" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <5 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) As (SNOMED CT#47809000 "Arsenic (substance)")
Generated Narrative: Observation Resource Observation "7fe7ccd7-6449-0186-2282-3eeb4cf6a796" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Generated Narrative: Observation Resource Observation "be016630-8754-7414-9014-21e020ad66c7" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Generated Narrative: Observation Resource Observation "92568f68-78f3-908c-6935-ff5f3d574dd7" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Hg (SNOMED CT#45262002 "Mercury (substance)")
Generated Narrative: Observation Resource Observation "a0ba0f6d-8ec0-846a-a70d-f6bca6d01a12" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <50 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Generated Narrative: Observation Resource Observation "d8533dcb-03f8-5997-6ccf-4f9b6f7a5745" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <50 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Generated Narrative: Observation Resource Observation "7cec19a2-34a7-6b80-3d60-083b2cc64fcb" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <50 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Co (SNOMED CT#54808007 "Cobalt (substance)")
Generated Narrative: Observation Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e7" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Generated Narrative: Observation Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1899" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Generated Narrative: Observation Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c78" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: <10 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) V (SNOMED CT#18925001 "Vanadium (substance)")
Generated Narrative: Observation Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e8" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Generated Narrative: Observation Resource Observation "6a78bcde-4781-226c-946e-a4b6915c1890" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Generated Narrative: Observation Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c79" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: ND Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Ni (SNOMED CT#33396006 "Nickel (substance)")
Generated Narrative: Observation Resource Observation "27aa47fd-7964-4f96-6495-b2bec7f160e9" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 250 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Generated Narrative: Observation Resource Observation "6a78bcde-4781-226c-946e-a4b6915c189b" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/a9dfda53-734b-045f-7ae4-94a6281d53bc effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 223 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Generated Narrative: Observation Resource Observation "f9f11088-7527-947c-3d3f-e71b32e13c70" status: final code: Degradation Products (Example Local Codes - Drug#DGP) subject: See on this page: Medication/c6f5fadd-62e6-3a01-93d9-b3b182f67d06 effective: 2023-01-01 12:00:00+0000 performer: See on this page: Organization/e3d2bc19-2f10-2b4d-1741-e4135fe612a9 value: 199 ppm (Details: UCUM code [ppm] = '[ppm]') Components - Code Value[x] * Impurity (Example Local Codes - Drug#IMP) Cu (SNOMED CT#66925006 "Copper (substance)")
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a3" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 1 () Codes - Code * Cadmium (substance) (SNOMED CT#66586000)
Impurity Classification - Mutagenic and Carcinogenic Potential
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a4" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 1 () Codes - Code * Lead (substance) (SNOMED CT#88488004)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a5" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 1 () Codes - Code * Arsenic (substance) (SNOMED CT#47809000)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a6" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 1 () Codes - Code * Mercury (substance) (SNOMED CT#45262002)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a7" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 2 () Codes - Code * Cobalt (substance) (SNOMED CT#54808007)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a8" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 2 () Codes - Code * Vanadium (substance) (SNOMED CT#18925001)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a9" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 2 () Codes - Code * Nickel (substance) (SNOMED CT#33396006)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "fec78d02-1ec2-48ac-bab3-5ed8b6adf9a0" Properties - Type Value[x] * Impurity Classification - Mutagenic and Carcinogenic Potential (Substance Property - example#impurityClassificationMCP) Class 3 () Codes - Code * Copper (substance) (SNOMED CT#66925006)
Generated Narrative: MedicinalProductDefinition Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" description: Textual description of the product combinedPharmaceuticalDoseForm: Gastro-resistant tablet (standardterms.edqm.eu#10225000) route: Oral use (standardterms.edqm.eu#20053000) Impurities - Reference * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a3 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a4 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a5 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a6 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a7 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a0 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a8 * See on this page: SubstanceDefinition/fec78d02-1ec2-48ac-bab3-5ed8b6adf9a9 name productName: Stelbat Tablets, 20mg type: Proprietary (Product Name Type - example#Proprietary) Parts - Part Type * 20mg Strength part (Product Name Part Type#StrengthPart)
Generated Narrative: Organization Resource Organization "e3d2bc19-2f10-2b4d-1741-e4135fe612a9" 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: Advanced Analytical Testing Laboratories Inc. Contacts - Address * 30 Silverline Drive North Brunswick New Jersey 08902 USA
Advanced Analytical Testing Laboratories Inc.