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Topamax Sprinkle
[(3aS,5aR,8aR,8bS)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methyl sulfamate

Molecular Formula:C12H21NO8S
Molecular Weight:339.36200

Appearance and properties: white to off-white crystalline powder
Density: 1.336 g/cm3
Boiling point: 438.7ºC at 760 mmHg
Melting point: 125ºC Flash point: 219.1ºC
Refractive index: 1.497
Stability: Stable if stored as directed.
Storage conditions: 2-8ºC

Items of Analysis Test Results Results
Appearance White to off-white powder White powder
Solubility Freely soluble in dichloromethane Conform
Identification Infrared Absorption Conform
The retention time of the major peak  of the sample solution corresponds to that of the Standard solution, as obtained in the Assay Conform
Specific rotation Between -28.6°and -35.0°,measured at 20° -31.1°
Water ≤0.5% 0.16%
Residue on ignition ≤0.2% 0.07%
Heavy metals ≤10ppm Conform
Related compounds by HPLC Fructose not more than 0.3% No detected
Compound A not more than 0.3% 0.13%
Other individual impurity not more than 0.1% 0.08%
Total impurities not more than 0.5% 0.27%
Sulfamate and sulfate Sulfamate ion not more than 0.10% No detected
Sulfate ion not more than 0.10% No detected
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. 99.4%
Residual solvent 1,2-dichloroethane not more than 5ppm No detected
Pyridine not more than 100ppm 12ppm
Ethanol not more than 1000ppm 581ppm
MIBK not more than 1000ppm 13ppm
Acetone not more than 1000ppm 7ppm
Conclusion The material complies with respect to USP38


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