O-Methyl Dolutegravir Impurity

O-Methyl Dolutegravir Impurity product with CAS: 1335210-35-9 is also known as (4R,12AS)-N-(2,4-Difluorobenzyl)-7-methoxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Dolutegravir impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (4R,12AS)-N-(2,4-Difluorobenzyl)-7-methoxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.