- E-mail : info@unihealthcarepharm.org
This medication is used with other medications (levodopa/carbidopa) to treat Parkinson's 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 in toluene; 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. |
