Appearance: | White or Light Yellow Powder. |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Common Name: | Valsartan Methyl Ester | |
Synonym: | L-Valine, N-(1 -oxopentyl)-N-[[2'-(1 H-tetrazole-5-yl)-[1,1 '-biphenyl]-4-yl]methyl]-, methyl ester | |
TEST | SPECIFICATION | RESULT |
Appearance | White or light yellow powder. | Conform |
Purity (HPLC) | 92.00% Min. | 99.58% |
Valsartan | 6.00% Max. | 0.11% |
Amide Methyl Ester(a) | 0.50% Max. | 0.03% |
Secondary Amine Methyl Ester(b) | 0.20% Max. | N.D.4 |
2-Cyano-4,-Bromomethylbiphenyl | 0.10% Max. | 0.03% |
Related Substances (HPLC) Impurity A1 Impurity B2 Impurity C3 |
2.00%max 0.05% Max. 0.05% Max. |
0.40% N.D. N.D. |
Total impurities | 2.00% Max.excl.Valsartan | 0.3% |
Water (LOD) | 1.00% Max | 0.24% |
(a) L-Valine,N-[(2'-cyano[1,1'-biphenyl]methyl]-,methyl ester(CAS:137863-89-9) | ||
(b)L-Valine,N-[(2'-cyano[1,1'-biphenyl]methyl]-N-(1-oxopentyl)-,methyl ester(CAS:137863-90-2) | ||
1 N-[2'-(1H-teteazol-5-yl)biphenyl-4-yl methyl]-N-valeryl-(D)-valine methyl ester 2 N-[2'-(1H-teteazol-5-yl)biphenyl-4-yl methyl]-N-butyryl-(L)-valine methyl ester 3 N-[2'-(1H-teteazol-5-yl)biphenyl-4-yl methyl]-N-valeryl-(L)-valine benzyl ester 4 N.D.:Not Detected |