5-Hydroxy Valsartan
| CAS No. | : 1186103-57-0 |
| Mol F. | : C24H29N5O4 |
| Mol W. | : 451.52 |
| Cat No. | : SA33306 |
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Description
| Product Name | 5-Hydroxy Valsartan |
| Synonyms | (2S)-3-Methyl-2-({[2′-(1H-1,2,3,4-tetrazol-5-yl)-4-biphenylyl]methyl}(5-hydroxyvaleryl)amino)butyric acid |
| Related API | Valsartan |
| Category | Impurities |
5-Hydroxy Valsartan product with CAS: 1186103-57-0 is also known as (2S)-3-Methyl-2-({[2′-(1H-1,2,3,4-tetrazol-5-yl)-4-biphenylyl]methyl}(5-hydroxyvaleryl)amino)butyric acid. 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 Valsartan impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, (2S)-3-Methyl-2-({[2′-(1H-1,2,3,4-tetrazol-5-yl)-4-biphenylyl]methyl}(5-hydroxyvaleryl)amino)butyric acid 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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