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Home » Active Pharmaceuticals Ingredients » Ondensetron HCl

Ondensetron HCl

Product Name Ondensetron HCl BP/EP/USP
Chemical Name 1,2,3,9-Tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one monohydrochloride dihydrate
CAS Number 103639-04-9
Chemical Formula C18H19N3O • ClH • 2H2O
Molecular Mass 365.9 g/mol
Therapeutic Category Antagonists

Specification of Ondensetron HCl :

Test Specification
Description White to off white powder.
Solubility Sparingly soluble in water and in alcohol, soluble in methanol, Slightly soluble in MDC.
Identification a) IR : The infra red absorption spectrum of the test sample exhibits maxima only at the same wavelengths as that of the working standard
b) Chloride test
Impurity B (by TLC) Impurity C : NMT 0.2%
Impurity D : NMT 0.1%
Impurity E : NMT 0.2%
Impurity F : NMT 0.2%
Total impurities : NMT 0.4%
Water 9.0 to 10.5%
Sulphated ash NMT 0.1%
Assay Should be between 97.5% to 102% (Anhydrous basis)

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