Description
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. |
Additional Information
The most widely recognized markets for this item incorporate the accompanying nations. If you don’t mind ask with us if your nation or district isn’t recorded:
ASIA: Afghanistan, Israel, Jordan, Pakistan, Russia, Saudi Arabia, Singapore, Syria, Philippines, Turkey, Turkmenistan, Uzbekistan, Yemen, Vietnam, Indonesia, Malaysia, Iran, Tajikistan, and so forth.
AFRICA: South Africa, Uganda, Nigeria, Ghana, Kenya, Mauritius, Botswana, Egypt, Ethiopia, Libya, Sudan, Congo, Gambia, Ivory Coast , and so forth.
NORTH & SOUTH AMERICA: USA, Canada, Panama, Trinidad and Tobago, Costa Rica, Puerto Rico, Dominican Republic, Argentina, Guatemala, Guyana, Peru, Bolivia, Venezuela , Brazil, Bahamas, Ecuador, and so forth .
EUROPE: Austria , Azerbaijan, Belarus, Belgium, Cyprus, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Ireland, Iceland, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom (UK) , Latvia, and so forth.
OCEANIA: Australia, New Zealand, Fiji, and so forth.
