| CAS No. | 5568-90-1 |
| Molecular Formula | C17H20N2S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
CATO manufactures Promethazine EP Impurity B HCl 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.
As a process- or degradation-related impurity, Promethazine EP Impurity B HCl (CAS 5568-90-1, C17H20N2SHCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality, chlorine substitution, Promethazine EP Impurity B HCl is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 320.88 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 | C17H20N2S HCl |
| Molecular Weight | 320.88 g/mol |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1958 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |