| CAS No. | 1309048-48-3 |
| Molecular Formula | C18H35ClN2O11P2S |
| Molecular Weight | 584.94 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
As a process- or degradation-related impurity, Clindamycin Phosphate EP Impurity I (CAS 1309048-48-3, C18H35ClN2O11P2S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to an amide group, a sulfone group, a phosphate ester group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Clindamycin Phosphate EP Impurity I is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 584.94 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.
| Molecular Formula | C18H35ClN2O11P2S |
| Molecular Weight | 584.94 g/mol |
| Purity | >90% |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 2.0 |
| CAS Registry Year (est.) | 1990 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |