CAT. No. | CP-C26009 |
---|---|
CAS. No. | NA |
Mol. F. | C18H35ClN2O11P2S |
Mol. Wt. | 584.95 |
Stock Status | In Stock |
Clindamycin Phosphate EP Impurity I is an impurity that may form during the synthesis, storage, or handling of Clindamycin Phosphate formulations.
Regulatory agencies require monitoring impurities like Clindamycin Phosphate EP Impurity I to ensure the safety and efficacy of Clindamycin formulations.
It forms as a by-product under specific conditions such as temperature and pH changes during synthesis or storage.
Proper storage conditions, quality checks, and pH management help minimize the formation of this impurity.
GC-MS, LC-MS, and HPLC-MS are commonly used methods for accurate detection and profiling of Clindamycin Phosphate EP Impurity I.
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 I as a reference standard, supporting regulatory compliance, method validation, and impurity profiling in Clindamycin formulations.