Clindamycin Phosphate EP Impurity I is a impurity of clindamycin phosphate, it is used to treat various bacterial infections. Impurity I plays a critical role in pharmaceutical quality control, serving as a reference standard for precise analytical testing. This testing enables the accurate identification and quantification of Impurity I within clindamycin phosphate-based medications, ensuring their purity and compliance with stringent regulatory standards. Buy high quality Clindamycin Phosphate EP Impurity I from Chemicea Pharma. Chemecia Pharma is one of the leading manufacturer and exporter of Clindamycin Phosphate EP Impurity I

Clindamycin Phosphate EP Impurity I

CAT. No. CP-C26009
CAS. No. NA
Mol. F. C18H35ClN2O11P2S
Mol. Wt. 584.95
Stock Status In Stock
Sample PDF VIEW COA Sample PDF VIEW MSDS
  • Category: Impurity Standards
  • Synonyms: Clindamycin 2,4-bisphosphate (EP) ;Clindamycin 2,4-Diphosphate
  • Chemical Name: Methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S,4R)-1-methyl-4-propylpyrrolidin-2-yl]carbonyl]amino]-2,4-di-O-phosphono-1-thio-L-threo-α-D-galacto-octopyranoside (as per EP)

FAQ

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.

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