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: Off-white, crystalline powder. Melts at about 144°. Practically insoluble in nonpolar organic solvents; slightly soluble in semipolar organic solvents; sparingly soluble in water; soluble in alcohol; freely soluble in methanol and in dimethylformamide. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: - IR spectrum - HPLC |
comparison with reference substance spectrum the retention time of the major peak in the chromatogram of test solution corresponds to that in the chromatogram of standard solution |
USP |
| Specific rotation | - 41.00 to – 43.50 | USP |
| Loss on drying | not more than 1.0% | USP |
| Residue on ignition | not more than 0.2% | USP |
| Heavy me |
not more than 0.001% | USP |
| Chromatographic purity: - single impurity about relative retention time about 1.10 - each other single impurity - total impurities |
not more than 1.0% not more than 0.3% not more than 2% |
USP |
| 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 |
| Content of enalapril maleate calculated on dried substance | 98.0% - 102.0% | USP |
Latest news
CEP for Baclofen available
Monday, 02-01-2012
Polpharma has been granted Certificate of Suitability (CEP) by the European Directorate for the Quality of...
Polpharma – the most innovative company in Poland
Friday, 20-05-2011
Polpharma ranked first as the most innovative company in Poland, in a research study run by the Institute...
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex
Friday, 08-10-2010
Polpharma has inaugurated a new state of the art 300 sq.m. Process Development Labs complex for the...
Co-operation between Polpharma and RPG Life Sciences
Tuesday, 05-10-2010
RPGLS and Polpharma announced their co-operation in the development and manufacture of Active...