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  • Acetylcholinesterase Inhibitor Donepezil Treating Dementia CAS: 120014-06-4

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    • Specifications

    Acetylcholinesterase Inhibitor Donepezil Treating Dementia CAS: 120014-06-4

    Abstract

    Donepezil is a centrally acting reversible acetylcholinesterase inhibitor. Its main therapeutic use is in the palliative treatment of Alzheimer’s disease. Common side effects include gastrointestinal upset. It has an oral bioavailability of 100% and easily crosses the blood-brain barrier. Because it has a biological half-life of about 70 hours, it can be taken once a day.

    Donepezil has been tested in other cognitive disorders (and is sometimes used off label) including Lewy body dementia and vascular dementia, but it is not currently approved for these indications. Donepezil has been found to improve sleep apnea in Alzheimer’s patients. Donepezil has also been studied in patients with Mild Cognitive Impairment, schizophrenia, attention deficit disorder, post-coronary bypass cognitive impairment, cognitive impairment associated with multiple sclerosis, CADASIL, and Down syndrome.

    A 3 year NIH trial in patients with mild cognitive impairment reported that donepezil was superior to placebo in delaying rate of progression to dementia during the initial 18 months of the study but this was not sustained at 36 months. In a secondary analysis, a subgroup of individuals with the Apolipoprotein E4 genotype showed sustained benefits with donepezil throughout the study. However at this time donepezil is not indicated for prevention of dementia. Recent studies suggest that Donepezil can improve speech in children with autism. The studies found that speech of autistic children who were mild to moderately affected appeared to improve from the use of Donepezil.

    Specification

    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

    Application

    Donepezil is used to treat confusion (dementia) related to Alzheimer’s disease. It does not cure Alzheimer’s disease, but it may improve memory, awareness, and the ability to function. This medication is an enzyme blocker that works by restoring the balance of natural substances (neurotransmitters) in the brain.

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