Topiramateis an new anticonvulsant (antiepilepsy) drug.
Storage:stored in sealed containers, cool and dry place, away from light and heat.
ITEM TESTED
STANDARD
RESULTS
Identification
Infrared Absorption
Complies
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
Complies
Appearance
White to off-White Powder
Complies
Specific rotation
Between -28.6° and -35.0°,measured at 20°
-31.50°
Solubility
Freely soluble in Dichloromethane
Complies
Water
Not more than 0.5%
0.1%
Residue on Ignition
Not more than 0.2%
0.07%
Heavy metals
Not more than 10ppm
Complies
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%
Fructose 0.07%
Compound A 0.05%
individual impurity 0 %
Total impurities 0.12%
Limit of sulfamate
and sulfate
Sulfamate ion not more than 0.10%;
Sulfate ion not more than 0.10%.
Complies
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.
99.88%
The material complies with respect to USP 33
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