Details:
Identification:
Infrared Absorption
The retention time of the major peak in the
chromatogram of the Assay preparation
corresponds to that in the chromatogram of
the Standard preparation , as obtained in the Assay
Appearance :White to off-White Powder
Specific rotation Between :-28.6° and -35.0°,measured at 20°
Water :Not more than 0.5%
Residue on Ignition :Not more than 0.2%
Heavy metals: Not more than 10ppm
Related compounds by TLC
Related compounds by HPLC
(Test 1)
Fructose: not more than 0.3%
Compound A: not more than 0.3%
Other individual impurity: not more than 0.1%
Total impurities: not more than 0.5%
Limit of sulfamate
and sulfate
Sulfamate ion not more than 0.10%;
Sulfate ion not more than 0.10%.
Assay:
Topiramate contains not less than 98.0% and
not more than the equivalent of 102.0% of
C12H21NO8S, calculated with reference to the
Anhydrous Basis.