4-Hydroxy Valsartan
| CAS No. | : 188259-69-0 |
| Mol F. | : C24H29N5O4 |
| Mol W. | : 451.52 |
| Cat No. | : SA33305 |
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Description
| Product Name | 4-Hydroxy Valsartan |
| Synonyms | (S)-N-(4-Hydroxy-1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-valine
(2S)-3-Methyl-2-({[2′-(1H-1,2,3,4-tetrazol-5-yl)-4-biphenylyl]methyl}-N-valerylamino)butyric acid |
| Related API | Valsartan |
| Category | Impurities |
4-Hydroxy Valsartan product with CAS: 188259-69-0 is also known as (S)-N-(4-Hydroxy-1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-valine. 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, (S)-N-(4-Hydroxy-1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-valine 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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