Current API product portfolio
Diclofenac sodiumSpecification:
|
|
| chemical name: | sodium 2-[(2,6-dichlorophenyl)amino]phenyl]acetate |
| molecular formula: | C14H10Cl2NNaO2 |
| structural formula: |  |
| molecular weight: | 318.1 |
| CAS Registery number: | 15307-79-6 |
General information: White or slightly yellowish crystalline powder, slightly hygroscopic, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, slightly soluble in acetone. It melts at 2800 with decomposition. |
|
| TESTS | REQUIERMENTS | METHODS |
|---|---|---|
| Identification: A. IR spectrum B. TLC C. chemical D. chemical |
comparison with reference substance spectrum the principal spot in the chromatogram is similar in position and size to the principal spot in the chromatogram obtained with reference solution conforms conforms |
Ph. Eur. |
| Appearance of 5% solution in methanol | the solution is clear, the absorbance measured at 440 nm is not greater than 0.05 | Ph. Eur. |
| Related substances (HPLC): - single impurity - total impuritie |
not more then 0.2% not more then 0.5% |
Ph. Eur. |
| Heavy me |
not more than 10 ppm | Ph. Eur. |
| Loss on drying | not more than 0.5% | Ph. Eur. |
| Content of diclofenac sodium calculated on driad substance | 99.0% to 101.0% | Ph. Eur. |
| Residual solvents: - methanol - 2-propanol - chlorobenzene - n-butanol |
not more than 1500 ppm not more than 2500 ppm not more than 180 ppm not more than 2500 ppm |
POLPHARMA |
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