| CAS No. | CATO-C4X-121341 |
| Molecular Formula | C16H21NO4 |
| Molecular Weight | 291.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Roxatidine Impurity 41 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
Roxatidine Impurity 41 (CAS CATO-C4X-121341) is a certified pharmaceutical impurity reference standard with the molecular formula C16H21NO4 and a molecular weight of 291.34 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Roxatidine Impurity 41 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 291.34 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.
| Molecular Formula | C16H21NO4 |
| Molecular Weight | 291.34 g/mol |
| Appearance | Off-white to pale yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 1 |