Yellow
crystalline powder. No visible evidence of contamination
by foreign matter.
Identification
a. Infrared Spectrum
is concordant with reference standard
b: TLC: The retention time of the principle spot in the
test solutions is identical with that of principle spot
in the reference solution
Melting Point
134 – 137oC
Residue on Ignition
Not more than 0.2%
Heavy Metals
Not more than 20ppm
Water
Not more than 1.0%
Related
Compounds (TLC-1)
Single
Impurity: Not more than 0.5%
Total Impurities: Not more than 1.0%
Related
Compounds (TLC-2)
Single
Impurity: Not more than 0.5%
Total Impurities: Not more than 1.0%
Assay
99.0
to 101.0% on an anhydrous basis
Clarity
of Solution
a.
Not more than 5.0 FTU
b. Clear solution.
Residual
Solvents
Ethanol:
Not more than 2000ppm
Total: Not more than 2000ppm