| CAS No. | 210095-58-2 |
| Molecular Formula | C17H19ClN2O |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Bepotastine Impurity 4.
Bepotastine Impurity 4 (CAS 210095-58-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H19ClN2OC4H6O6 and a molecular weight of 452.89 g/mol.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Bepotastine Impurity 4 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 452.89 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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.
CATO manufactures Bepotastine Impurity 4 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.
| Molecular Formula | C17H19ClN2O C4H6O6 |
| Molecular Weight | 452.89 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2017 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |