This medication is used with other medications (levodopa/carbidopa) to treat Parkinson disease. Entacapone belongs to a class of drugs known as COMT inhibitors.
Specification:
TEST | SPECIFICATION | RESULT |
Appearance | Greenish yellow to yellow crystalline powder | Yellow crystalline powder |
Identification by IR | Test IR spectrum should be concordant with reference spectrum | Complies |
Solubility | Sparingly soluble in acetone and methanol; slightly soluble in ethanol, chloroform, isopropanol, and ether, very slightly soluble ; practically in water | Complies |
Loss on drying | 0.5%max | 0.35% |
Heavy metals | Not more than 20ppm | <20ppm |
Residue on ingition | Not more than 0.1% | 0.06% |
Related substance
Impurity A Other unknown impurity Total impurity except Impurity A |
0.1%max 0.1%max 0.2%max |
0.03% 0.03% 0.09% |
Z-isomer | 0.05%max | 0.01% |
Assay(on dry basis) | 98.0%-102.0% | 99.91% |
Particle size | D90: less than 10microns | 8microns |
Storage | Cool and dry | |
Conclusion: | Up to the Standard of USP34 |
Packaging details:
Packaging details: | 25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
Storage: | Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
Shelf Life: | 5 years if sealed and store away from direct sun light. |
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