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Product name
|
LCZ696 |
CAS No.: | 936623-90-4 |
Item | Specifications |
Appearance | White to almost white power |
Identification | UV:The UV absorption spectrum of the sample must be concordant with R.S. |
HPLC:The retention time of the major peak in the chromatogram conforms to the characteristic peak of R.S. | |
Water | 4.0%-6.0% |
Related Substances | Impurity A: Not more than 1.2% |
Any other impurity: Not more than 0.2% | |
Total impurities: Not more than 1.5% | |
Stereoisomers | Impurity B: Not more than 0.5% |
Any other impurity: Not more than 0.2% | |
Heavy Metals | Not more than 20ppm |
Residual Solvents | Isopropyl acetate: Not more than 0.5% |
Acetone: Not more than 0.5% | |
Isopropanol: Not more than 0.5% | |
Assay (on the anhydrous basis) | Valsartan:49.0-53.0% |
Sacubitril:47.0-51.0% | |
(calculated as free acid on an anhydrous basis;equivalent to 97.0-102.0% |
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