Description

Cobicisat stage-II Impurity product with CAS: NA is also known as Ethyl (2s)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl] methyl} carbamoyl) amino]-4-(morpholin-4-yl) butanoate oxalate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Cobicisat stage-II Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Cobicistat and its related formulations. Moreover, Ethyl (2s)-2-[(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl] methyl} carbamoyl) amino]-4-(morpholin-4-yl) butanoate oxalate 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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