Current API product portfolio
Enalapril maleateSpecification:
|
|
| chemical name: | (2S)-1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl] pyrrolidine-2-carboxylic acid (Z)-butenedioate |
| molecular formula: | C24H32N2O9 |
| structural formula: |  |
| molecular weight: | 492.5 |
| CAS Registery number: | 76095-16-4 |
General information: Appearance: white or almost white, crystalline powder. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: - IR spectrum |
comparison with reference substance spectrum |
Ph. Eur. |
| Appearance of solution | the solution is clear and colourless | Ph. Eur. |
| pH | 2.4 to 2.9 | Ph. Eur. |
| Specific optical rotation | - 48° to - 51° | Ph. Eur. |
| Related substances: - impurity A - other known impurity - other unknown impurity - total impurities (except imp. A) |
not more than 1.0% not more than 0.3% not more than 0.10% not more than 1.0% |
Ph. Eur. |
| Heavy me |
not more than 10 ppm | Ph. Eur. |
| Loss on drying | not more than 1.0% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of enalapril maleate calculated on dried substance | 98.5% - 101.5% | Ph. Eur. |
| Residual solvents: - methylene chloride - cyclohexane - ethanol - isopropanol |
not more than 300 ppm not more than 2000 ppm not more than 2500 ppm not more than 2500 ppm |
POLPHARMA |
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