Entacapone

Entacapone

Product Details:

X

Product Description

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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