Description

Cobicistat Cyclized impurity product with CAS: NA is also known as Ethyl (4S)-2-(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}amino)-5,6-dihydro-4H-1,3-oxazine-4-carboxylate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Cobicistat Cyclized impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Cobicistat and its related formulations. Moreover, Ethyl (4S)-2-(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}amino)-5,6-dihydro-4H-1,3-oxazine-4-carboxylate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.

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