| CAS No. | CATO-C4X-134158 |
| Molecular Formula | C18H30Cl4N2O2S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a process- or degradation-related impurity, Clindamycin Impurity 58 (CAS CATO-C4X-134158, C18H30Cl4N2O2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Clindamycin Impurity 58 is typically white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 480.31 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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), Clindamycin Impurity 58 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 | C18H30Cl4N2O2S |
| Molecular Weight | 480.31 g/mol |
| Purity | 97%+ |
| 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) | 3.0 |
| UV Absorption | UV-absorbing |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |