Toiramate

Items

Specifications

Results

Appearance

White to off-white powder, Freely  soluble in dichloromethane

White powder, Freely soluble in   dichloromethane

Identification

Infared Absorption

Complies

The retention time of the major peak   in the chromatogram of the Assay prepration corresponds to that in the   chromatogram of the standard preparation, as obtained in the assay

complies

Specific rotation

Between -28.6°and -35.0°, measured at   20°

-32.8°

Water

not more than 0.5%

0.12%

residue on ignition

not more than 0.2%

0.11%

Heavy metals

not more than 0.001%

complies

related compounds by HPLC(Test1)

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:   0.03%           Compound   A: 0.04%     individual impurity   0             Total   impurities: 0.07%

Particle size

90% less than 350 microns

complies

Limit of sulfamate and sulfate

Sulfamate ion not more than 0.10%   Sulfate ion not more than 0.10%

complies

Residual Solvent

Methylene Chloride not more than   250μg/g

not detected

Acetone not mor than 2500μg/g

Isopropanol not more than 5000μg/g

Ethanenitrile not more than 400μg/g

n-hexane not more than 290μg/g

Ethyl Acetate not more than 2500μg/g

Pyridine not more than 100μg/g

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

99.80%

Conclustion

The material complies with respect to   USP32