Current API product portfolio
BaclofenSpecification:
|
|
| chemical name: | (3RS)-4-amino-3-(p-chlorophenyl)butanoic acid |
| molecular formula: | C10H12ClNO2 |
| structural formula: |  |
| molecular weight: | 213.66 |
| CAS Registery number: | 1134-47-0 |
General information: A white or almost white powder, slightly soluble in water, very slightly soluble in alcohol, practically insoluble in acetone. It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. It shows polymorphism. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: First identification: B. Second identification: A, C. A. UV-Vis spectrum B. IR spectrum C. TLC |
the specific absorbances at these maxima are 9.8 to 10.8, 11.5 to 12.7 and 8.4 to 9.3 comparison with reference substance spectrum the principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution |
Ph. Eur. |
| Appearance of solution (0.50 g / 25 ml 1M NaOH) |
the solution is not more opalescent than reference suspension II and not more intensely coloured than reference solution BY5 | Ph. Eur. |
| Related substances: liquid chromatography: - impurity A - sum of impurities |
not more than 1.0% not more than 2% |
Ph. Eur. |
| Water | not more than 1.0% | Ph. Eur. |
| Sulphated ash | not more than 0.1% | Ph. Eur. |
| Content of baclofen calculated with reference to the anhydrous substance | 98.0% - 101.0% | Ph. Eur. |
| Residual solvents: - methanol - ethanol |
not more than 800 ppm not more than 500 ppm |
POLPHARMA |
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...