Current API product portfolio
Metoprolol succinateSpecification:
|
|
| chemical name: | (4-amino-1-hydroxybutylidene)bisphosphonic acid monosodium salt trihydrate |
| molecular formula: | C34H56N2O10 |
| structural formula: |  |
| molecular weight: | 653 |
| CAS Registery number: | 98418-47-4 |
General information: White to off-white powder. Freely soluble in water; soluble in methanol; sparingly soluble in alcohol; very slightly soluble in isopropyl alcohol. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Clarity and color of solution | solution is not less clear than an equal volume of water; the absorbance of the solution is not more than 0.1 | USP |
| Identification: - IR |
comparison with reference substance spectrum |
USP |
| pH | between 7.0 and 7.6 | USP |
| Loss on drying | not more than 0.2% | USP |
| Residue on ignition | not more than 0.1% | USP |
| Heavy me |
not more than 0.001% | USP |
| Relative substances: a) test 1 (TLC): - single impurity b) test 2 (HPLC): - single impurity - sum of impurities |
not more than 0.2% not more than 0.1% not more than 0.5% |
USP |
| Content of Metoprolol Succinate calculated on dried substance | 98.0% - 102.0% | USP |
| Residual solvents: - acetone - toluene |
not more than 2500 ppm not more than 100 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...