Donepezil, marketed under the trade name Aricept, is a medication used in the palliative treatment of Alzheimer's disease. Donepezil is used to improve cognition and behavior of people with Alzheimer's, but does not slow the progression of or cure the disease.
Common side effects include loss of appetite, gastrointestinal upset, diarrhea, difficulty sleeping, vomiting, or muscle cramping.
It was developed by Eisai and Pfizer and is sold as a generic by multiple suppliers. Donepezil acts as a centrally acting reversible acetylcholinesterase inhibitor.
Medical uses
Alzheimer's disease
There is no evidence that donepezil or other similar agents alters the course or progression of Alzheimer's disease (AD). 6 to 12-month controlled studies have shown modest benefits in cognition and/or behavior. The UK National Institute for Clinical Excellence (NICE) recommends donepezil as an option in the management of mild to moderate Alzheimer's disease. The person should, however, be reviewed frequently and if there is no significant benefit it should be stopped. In 2006 the U.S. Food and Drug Administration also approved donepezil for treatment of mild, moderate and severe dementia in Alzheimer's disease.
Description
Superlist Name:Donepezil
Molecular Formula:C24H29NO3
CAS No.:120014-06-4
Synonyms:2-[(1-Benzyl-4-piperidyl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one
Molecular Weight:379.49
Appearance:white powder
Melting Point: 207 °C
Application:Shown to increase levels of cortical acetylcholine
Specifications:
| TEST ITEM | SPECIFICATION | RESULT |
| Appearance | Off white to white crystalline powder | Complies |
| Solubility |
freely Freely soluble in chloroform, soluble
in water and Acetic acid, slightly soluble in
Acetonitrile and ethanol, insoluble in
Ethylacetoacetate and n-hexane
| Complies |
| Identification |
(1)By IR absorption ,To match with working
standard
| Complies |
(2) The retention time of the major peak of
the sample should accord with that of the
working standard.
|
Complies
| |
(3) Test for chlorides. Reponds to the test
for Chlorides.
|
Complies
| |
| PH | 4.0-7.0 | 6.10 |
| Residue on ignition | ≤0.1% | 0.03% |
| Related substance |
Any Unkonwn single impurity≤0.3%
Total ≤0.5%
|
0.04%
0.18%
|
| Heavy metal | ≤10ppm | <10ppm |
| Residual Solvents |
Methanol≤0.3%
Ethanol≤0.5%
Ethyl acetate≤0.5%
Toluene≤0.089%
Acetic acid≤0.5%
|
Not detected
Not detected
Not detected
Not detected
Not detected
|
| Loss on drying | ≤0.5% | 0.20% |
| Assay |
On dried base, C24H29NO3·HCl
should be 98.0% to 102.0%
| 100.20% |
| Conclusion: The product complies to Enterprise standard | ||
Packing&Storage of
Package: 25kgs/drum,double plastic-bag inside, aluminum foil bag or fiber drum outside.
Storage: Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat.
Shelf Life:Two years when properly stored.
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