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: White to off-white, crystalline powder. Is odorless or practically so. Slightly soluble in water; very slightly soluble in methanol; insoluble in chloroform. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: - IR spectrum |
comparison with reference substance spectrum |
USP |
| Water | not more than 3.0% | USP |
| Residue on ignition | not more than 0.3% | USP |
| Heavy me |
not more than 0.001% | USP |
| Related compounds: - sum of impurities |
not more than 2.0% |
USP |
| Content of baclofen calculated with reference to the anhydrous substance | 99.0% - 101.0% | USP |
| Residual solvents: - methanol - ethanol |
not more than 800 ppm not more than 500 ppm |
POLPHARMA |
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