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Product Name | Donepezil 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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