Ondansetron EP Impurity B CAS 1076198-52-1
| CAS No. | 1076198-52-1 |
| Molecular Formula | C37H38N6O2 |
| Molecular Weight | 598.74 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Ondansetron EP Impurity B meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Ondansetron EP Impurity B (CAS 1076198-52-1) is a certified pharmaceutical impurity reference standard with the molecular formula C37H38N6O2 and a molecular weight of 598.74 g/mol.
Ondansetron EP Impurity B (C37H38N6O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
Physical & Chemical Properties
| Molecular Formula | C37H38N6O2 |
| Molecular Weight | 598.74 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening |
| Degree of Unsaturation (DBE) | 22.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Nitrogen Atoms | 6 |
Related Ondansetron Standards
- Ondansetron Impurity 13 (CAS CATO-C4X-139413)
- Ondansetron Impurity 16 (CAS 126671-72-5)
- Ondansetron Impurity 12 (CAS 1365727-09-8)
- Ondansetron Impurity 14 (CAS 1365727-07-6)
- Ondansetron Impurity 13 (CAS 126671-73-6)
- Ondansetron Impurity 13 (CAS 1216890-42-4)
- Ondansetron Impurity 11 (CAS CATO-C4X-139411)
- Ondansetron Impurity 16 (CAS CATO-C4X-139416)
Recommended Standards
- Revefenacin Impurity 65 (CAS CATO-C4X-203165)
- ((2R,3R,4S,5R,6R)-3,4,5-tris(benzyloxy)-6-(p-tolylthio)tetrahydro-2H-pyran-2-yl)methyl acetate (CAS 1941225-54-2)
- Revefenacin Impurity 1 (CAS 909800-36-8)
- tert-Butyl ((S)-1-(((S)-1-cyclohexyl-2-((S)-2-(4-(4-hydroxybenzoyl)thiazol-2-yl)pyrrolidin-1-yl)-2-oxoethyl)amino)-1-oxopropan-2-yl)(methyl)carbamate (CAS 2222354-11-0)
- N-Nitroso Diphenhydramine EP Impurity A-d5 (CAS CATO-C4X-142419)
- Melitracen Impurity 13 (CAS 71264-79-4)
- Cinacalcet Impurity 91 (CAS CATO-C4X-105991)
- 5-(Difluoromethyl)furan-3-carboxamide (CAS 189330-19-6)
- 1-(2-Methylbenzyl)-3,4-dihydroisoquinoline (CAS 104330-69-0)
- (2-Ethoxyprop-1-en-1-yl)triphenylphosphonium iodide (CAS 62639-97-8)
- 2-Chloro-N,N-dimethyl-4-nitrobenzamide (CAS 90649-54-0)
- (4R,5R)-2-((E)-But-2-en-1-yl)-4,5-diphenyl-1,3,2-dioxaborolane (CAS 804565-69-3)
- Benzyl (R)-2-methyl-5-oxopiperidine-1-carboxylate (CAS 1616434-59-3)
- Endo-Gly29-Tirzepatide (CAS CATO-CPTD788685)
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