| CAS No. | 409314-72-3 |
| Molecular Formula | C4H10ClN |
| Molecular Weight | 107.58 g/mol |
| 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 Promethazine Impurity 72.
As a process- or degradation-related impurity, Promethazine Impurity 72 (CAS 409314-72-3, C4H10ClN) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Promethazine Impurity 72 (C4H10ClN) contains chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.
As a certified reference material (CRM), Promethazine Impurity 72 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.
| Molecular Formula | C4H10ClN |
| Molecular Weight | 107.58 g/mol |
| Purity | ≥95% |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 0.0 |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |