Clindamycin EP Impurity B CAS 18323-43-8
| CAS No. | 18323-43-8 |
| Molecular Formula | C17H31ClN2O5S |
| Molecular Weight | 410.96 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Clindamycin EP Impurity B (CAS 18323-43-8, C17H31ClN2O5S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C17H31ClN2O5S, Clindamycin EP Impurity B contains an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 410.96 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 EP Impurity B 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.
Physical & Chemical Properties
| Molecular Formula | C17H31ClN2O5S |
| Molecular Weight | 410.96 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 |
| CAS Registry Year (est.) | 1962 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
| Sulfur Atoms | 1 |
Related Clindamycin Standards
- Clindamycin EP Impurity A (CAS 154-21-2)
- Clindamycin-DeA (CAS CATO-C4X-134192)
- Clindamycin Impurity 95 (CAS CATO-C4X-134195)
- Clindamycin Impurity 96 (CAS CATO-C4X-134196)
- Clindamycin Impurity 66 (CAS CATO-C4X-134166)
- Clindamycin Impurity 149 (CAS CATO-C4X-1341149)
- Clindamycin Impurity 162 (CAS CATO-C4X-1341162)
- Clindamycin EP Impurity C (CAS 16684-06-3)
Recommended Standards
- Pirlimycin (CAS 79548-73-5)
- Ono-ae 1-259 (CAS 272771-50-3)
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- 433232-03-2 D02RUO ONO-8815Ly ONO-8815Lyn ONO-AE-1259 (CAS 433232-03-2)
- Teneligliptin Impurity 12 (CAS CATO-C4X-176012)
- Betahistine impurity 40 (CAS CATO-C4X-183840)
- Ibrutinib Impurity 6 (CAS 143900-44-1)
- 2-Amino-5-(2-chlorophenyl)pyrimidine-4-thiol (CAS 15937-38-9)
- 3-Fluoro-1-methylpiperidin-4-ol (CAS 1393100-32-7)
- 1-(2-hydroxyethyl)-1H-pyrazole-4-carboxamide (CAS 1849283-80-2)
- 5-((Dimethylamino)methyl)-N-methyl-1,3,4-oxadiazol-2-amine (CAS 732183-16-3)
- 2-Amino-4-(difluoromethyl)-6-(trifluoromethyl)nicotinaldehyde (CAS 1805372-62-6)
- 2-Methoxybenzamidoxime (CAS 771-28-8)
- Insulin Degludec Impurity 11 (CAS CATO-C4X-215711)
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