Enalapril Maleate CAS No 76095-16-4
| Items |
Standard |
Results |
| Description |
Off-white,crystalline powder |
Complies |
| Identification |
A:IR spectrum accordance with that of CRS |
Complies |
| B:Major peak in chromatogram obtain in the test solution in the assay accordance with that of reference solution |
Complies |
| Specific rotation |
-41.0°~-43.5° |
-41.8° |
| Loss on drying |
Not more than 1.0% |
0.07% |
| Residue on ignition |
Not more than 0.2% |
0.04% |
| Heavy metals |
Not more than 0.001% |
<0.001% |
| Related substances |
Enalaprilat:not more than 0.3% |
0.06% |
| Moexipril related compound F:not more than 0.3% |
<0.05% |
| Enalapril cyclohexyl analog:not more than 0.3% |
0.10% |
| Enalapril related compound D:not more than 0.3% |
<0.05% |
| Any unspecified impurity:not more than 0.10% |
0.05% |
| Total impurities:not more than 2.0% |
0.29% |
| Residual solvents |
Ethanol:not more than 5000ppm |
135ppm |
| Acetone:not more than 5000ppm |
N.D |
| Dichloromethane:not more than 600ppm |
N.D |
| n-Hexane:not more than 290ppm |
N.D |
| Assay(Calculated on the dried basis) |
98.0%~102.0% |
100.2% |
for customer reference only.
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