| CAS No. | CATO-C4X-141832 |
| Molecular Formula | C4H10ClN |
| 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 Promethazine lmpurity 32.
CATO supplies Promethazine lmpurity 32 (CAS CATO-C4X-141832), a pharmacopoeial impurity reference standard (molecular formula C4H10ClNHCl, MW 144.04 g/mol) used for the identification and quantification of trace impurities in APIs.
Promethazine lmpurity 32 (C4H10ClNHCl) 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 lmpurity 32 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 HCl |
| Molecular Weight | 144.04 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) | -1.0 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |