O-Methyl Dolutegravir Impurity
| CAS No. | : 1335210-35-9 |
| Mol F. | : C21H21F2N3O5 |
| Mol W. | : 433.41 |
| Cat No. | : SA20228 |
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Description
| Product Name | O-Methyl Dolutegravir Impurity |
| Synonyms | (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 |
| Related API | Dolutegravir |
| Category | Impurities |
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.
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