Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "substance1" manufacturer: See on this page: Organization/062bf235-44e2-55c4-9213-bbe5e12d5620 Names - Name * Stelbatolol relationship Extension - Impurity Origin PQ: Enantiomer of API SM (Impurity Origin Codes#enantiomer "Enantiomer") substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad1 type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#CH-IMP "Chiral Impurity") amount: ND relationship Extension - Impurity Origin PQ: Step 1a Process Impurity (Impurity Origin Codes#process "Process Impurity") substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad2 type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#PR-IMP "Process impurity") amount: Range: ND-0.2% relationship Extension - Impurity Origin PQ: Step 1a Process Impurity (Impurity Origin Codes#process "Process Impurity") substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad9 type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#PR-IMP "Process impurity") amount: Range: ND–0.3% relationship Extension - Impurity Origin PQ: API Starting Material (Impurity Origin Codes#starting-material "Starting Material") substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad3 type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#ST-IMP "Starting material, forced degradation product") amount: Observed only during stress studies relationship Extension - Impurity Origin PQ: API Process Intermediate (Impurity Origin Codes#intermediate-material "Intermediate Material") substanceDefinition: See on this page: SubstanceDefinition/03d68d1c-162c-8b6e-80f9-647b0ea97ad4 type: Impurity Of (Substance Relationship Type#Impurity; Impurity Type Codes#INT-IMP "Process intermediate, forced degradation product") amount: Observed only during stress studies
Starting material, forced degradation product
Process intermediate, forced degradation product
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad1" characterization technique: Enantiomeric purity by LC () characterization technique: Mass spectrometry () property type: Rule-based (Q)Sar (Substance Property - example#1233444) value: Negative (Substance Property Value - example#negative) property type: Statistical (Q)Sar (Substance Property - example#123555) value: Negative (Substance Property Value - example#negative) property type: ICH M7 Classification (Substance Property - example#123556) value: Class 5 (Substance Property Value - example#class-5) property type: Mutagenicity Comment (Substance Property - example#123557) value: Treated as non-mutagenic due to lack of alerting structure () MolecularWeights - Amount * 295.80 g/mole (Details: UCUM code g/mol = 'g/mol') structure Representations - Document * See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad1 Names - Name * R-enantiomer of stelbatalol
Treated as non-mutagenic due to lack of alerting structure
Generated Narrative: DocumentReference Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad1" status: current content Attachments - ContentType Data * image/x-png (base64 data - 4429 bytes)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad2" Characterizations - Technique * Organic impurities by HPLC () property type: Rule-based (Q)Sar (Substance Property - example#1233444) value: Negative (Substance Property Value - example#negative) property type: Statistical (Q)Sar (Substance Property - example#123555) value: Negative (Substance Property Value - example#negative) property type: ICH M7 Classification (Substance Property - example#123556) value: Class 5 (Substance Property Value - example#class-5) property type: Mutagenicity Comment (Substance Property - example#123557) value: Treated as non-mutagenic due to lack of alerting structure () MolecularWeights - Amount * 344.4 g/mole (Details: UCUM code g/mol = 'g/mol') structure Representations - Document * See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad2 Names - Name * Impurity 1
Generated Narrative: DocumentReference Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad2" status: current content Attachments - ContentType Data * image/x-png (base64 data - 7004 bytes)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad9" Characterizations - Technique * Organic impurities by LC () property type: Rule-based (Q)Sar (Substance Property - example#1233444) value: Negative (Substance Property Value - example#negative) property type: Statistical (Q)Sar (Substance Property - example#123555) value: Negative (Substance Property Value - example#negative) property type: ICH M7 Classification (Substance Property - example#123556) value: Class 5 (Substance Property Value - example#class-5) property type: Mutagenicity Comment (Substance Property - example#123557) value: Treated as non-mutagenic due to lack of alerting structure () MolecularWeights - Amount * 459.58 g/mole (Details: UCUM code g/mol = 'g/mol') structure Representations - Document * See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad9 Names - Name * Impurity 2
Generated Narrative: DocumentReference Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad9" status: current content Attachments - ContentType Data * image/x-png (base64 data - 7149 bytes)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad3" characterization technique: Organic impurities by HPLC () characterization technique: Chromatographic retention () property type: Rule-based (Q)Sar (Substance Property - example#1233444) value: Negative (Substance Property Value - example#negative) property type: Statistical (Q)Sar (Substance Property - example#123555) value: Negative (Substance Property Value - example#negative) property type: ICH M7 Classification (Substance Property - example#123556) value: Class 5 (Substance Property Value - example#class-5) property type: Mutagenicity Comment (Substance Property - example#123557) value: Treated as non-mutagenic due to lack of alerting structure () MolecularWeights - Amount * 144.173 g/mole (Details: UCUM code g/mol = 'g/mol') structure representation document: See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad3 representation type: SMILES (Substance Representation Format#SMILES) representation: OC1=CC2=C(C=C1)C=CC=C2 representation type: InChI (Substance Representation Format#InChI) representation: 1S/C10H8O/c11-10-6-5-8-3-1-2-4-9(8)7-10/h1-7,11H Codes - Code * 2-Naphthol (Chemical abstract codes#135-19-3) Names - Name * β-naphthol
Generated Narrative: DocumentReference Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad3" status: current content Attachments - ContentType Data * image/x-png (base64 data - 4093 bytes)
Generated Narrative: SubstanceDefinition Resource SubstanceDefinition "03d68d1c-162c-8b6e-80f9-647b0ea97ad4" characterization technique: Impurity content by LC-MS () characterization technique: UV spectroscopy () characterization technique: NMR spectroscopy () property type: Rule-based (Q)Sar (Substance Property - example#1233444) value: Positive (Substance Property Value - example#positive) property type: Statistical (Q)Sar (Substance Property - example#123555) value: Positive (Substance Property Value - example#positive) property type: ICH M7 Classification (Substance Property - example#123556) value: Class 2 (Substance Property Value - example#class-2) property type: Mutagenicity Comment (Substance Property - example#123557) value: Control at or below qualification threshold () MolecularWeights - Amount * 245.32 g/mole (Details: UCUM code g/mol = 'g/mol') structure Representations - Document * See on this page: DocumentReference/13d68d1c-162c-8b6e-80f9-647b0ea97ad4 Names - Name * 1-(Ethylamino)-3-(2-naphthyloxy)-2-propanol
Control at or below qualification threshold
Generated Narrative: DocumentReference Resource DocumentReference "13d68d1c-162c-8b6e-80f9-647b0ea97ad4" status: current content Attachments - ContentType Data * image/x-png (base64 data - 5119 bytes)
Generated Narrative: Organization Resource Organization "062bf235-44e2-55c4-9213-bbe5e12d5620" 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