Entacapone

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:

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.