Description

Tenofovir Disoproxil Fumarate IP Impurity C product with CAS: 1246812-43-0 is also known as Methyl (1-methylethyl) (5RS)-5-{[(1R)-2-(6-amino-9H-purin-9-yl)-1-methyl ethoxy]methyl}-5-oxo-2,4,6,8-tetraoxa-5-λ5-phosphanonanedioate fumarate; . This product can be used as a working standard or secondary reference standard (additional internal validation as per respective FDA regulations/guidelines may require). Tenofovir Disoproxil Fumarate IP Impurity C is used in Tenofovir impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines during commercial production of Tenofovir and its related formulations. Moreover, Methyl (1-methylethyl) (5RS)-5-{[(1R)-2-(6-amino-9H-purin-9-yl)-1-methyl ethoxy]methyl}-5-oxo-2,4,6,8-tetraoxa-5-λ5-phosphanonanedioate fumarate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation. Please also find out other impurities of Tenofovir developed in our R&D.

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