CAT. No. | CP-C26008 |
---|---|
CAS. No. | NA |
Mol. F. | C18H35ClN2O11P2S |
Mol. Wt. | 584.94 |
Stock Status | In Stock |
Clindamycin Phosphate EP Impurity H is an impurity that can occur in Clindamycin Phosphate formulations due to synthesis or storage conditions.
Regulatory bodies require monitoring impurities like Clindamycin Phosphate EP Impurity H to ensure the safety and efficacy of Clindamycin formulations.
It forms as a by-product under conditions such as temperature and pH variations during synthesis or storage.
Proper storage conditions, regular quality checks, and pH management help manage and minimize the formation of this impurity.
Detection methods include GC-MS, LC-MS, and HPLC-MS for precise impurity profiling and analysis.
Chemicea provides COA, H-NMR, MASS, HPLC, and TGA reports as standard, with additional reports like CNMR, IR, UV, DEPT, Water content, and CHNS available upon request.
Yes, Chemicea’s documentation meets standards required by major regulatory agencies such as USFDA, EMA, ANVISA, TGA, and PMDA.
It is stable for shipping at room temperature, with specific storage guidelines provided in the COA.
Yes, Chemicea offers both standard and customized pack sizes to meet specific client requirements.
Chemicea supplies Clindamycin Phosphate EP Impurity H as a reference standard, aiding in regulatory compliance, method validation, and impurity profiling for Clindamycin formulations.