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Home » Active Pharmaceuticals Ingredients » Donezepil Hydrochloride BP

Donezepil Hydrochloride BP

Product Name Donezepil Hydrochloride BP/EP/USP
Chemical Name (+)-2-[(1-Benzyl-4-piperidy)methyl-5,6-dimethoxy-1-indanone, hydrochloride
CAS Number 120011-70-3
Chemical Formula C24H29NO3.HCl
Molecular Mass 415.95 g/mol
Therapeutic Category -

Specification of Donezepil Hydrochloride :

Test Specification
Description White crystalline powder
Solubility Freely soluble in chloroform; soluble in water & glacial acetic acid; slightly soluble in alcohol & acetonitrile; practically insoluble in ethyl acetate & n-hexane.
Identification
A) By Infrared Absorption
B) By HPLC

C) By Chlorides

To match with Working / Reference standard
The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay.
To meet the test.
Inorganic Impurities A) Heavy Metals NMT 20ppm
B) Residue on ignition NMT 0.1% w/w
Specific Tests Water content by KF NMT 0.4% w/w
Organic Impurities By HPLC Desbenzyl donepezil NMT 0.20%
Hydroxydonepezil NMT 0.20%
Donepezil related compound A NMT 0.10%
Any individual unspecified impurity NMT 0.10%
Total impurities NMT 1.0%
Assay by HPLC (on anhydrous basis) NLT 98.0% & NMT 102% w/w
Additinational Test Residual solvents by HS GC Methanol NMT 3000ppm
Isopropyl alcohol NMT 5000ppm
Chloroform NMT 60ppm
Methl Isobutyl Ketone NMT 5000ppm
Toluene NMT 890ppm

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