Entacapone

Product Details:

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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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