Enalaprilat 76420-72-9 ENALAPRILAT HYDRATE;ENALAPRILAT USP(CRM STANDARD);Enalaprilic Acid;N-[(1S)-1-(Carboxy)-3-phenylpropyl]-L-alanyl]-L-proline Dihydrate;Vasotec IV;(2S)-1-[(2S)-2-[[(1S)-1-Carboxy-3-phenyl-propyl]amino]pr
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1. Specification of Enalaprilat
Items | Specifications | Results |
Appearance | A white crystalline powder | Complies |
Specific Rotation | -53°~56° | -54° |
Identification | UV: λmax=257nm | Complies |
The retention time of the major peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay | Complies | |
IR: Similar to reference substance | Complies | |
Water | 7.0%~11.0% | 10.90% |
Residue on ignition | Not more than 0.2% | 0.02% |
Heavy metals | Not more than 0.002% | Complies |
Related substances | ||
Total impurities | Not more than 1.0% | 0.11% |
Microbial contamination | ||
TAMC | Not more than 10cfu/g | 4cfu/g |
TYMC | Not more than 2cfu/g | 1cfu/g |
Assay | Not less than 98.0% (Calculated on the anhydrous basis | 98.50% |
Conclusion | It conforms to the above specification |
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