Appearance:White,oralmostwhitepowder Solubility:VeryslightlysolubleinwaterSparinglysolubleinacetoneSlightlysolubleinalcohol Identificati…
Appearance :White, or almost white powder
Solubility :Very slightly soluble in water Sparingly soluble in acetone Slightly soluble in alcohol
Identification A
A) IR vs Standard: The I.R. absorption
spectrum of the preparation of the test specimen exhibits maxima only at the
same wavelengths as that of a similar preparation of the standard.
B) A white precipitate is formed
C) An odor characteristic of methanesulfonic acid is perceptible
D) The color of permanganate is not discharged.
Melting range :Between 115℃ and 118℃
Loss on drying :Not more than 2.0%
Residue on ignition: Not more than 0.1%
Residual Solvents :In accordance with Q3C and Q3C (M)
ICH
Assay Between :98.0% and 100.5%
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