Topiramate - C12h21no8s, 98.0% Purity Minimum | White To Off-white Crystalline Powder, Usp 32 Certified Quality

We are offering our customers a wide range of Topiramate, which are available following Specifications :-
Chemical Name: 2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate
Other name: McN-4853; RWJ-17021; Topamax
CAS RN: 97240-79-4
Structural Formula:
Molecular formula & Molecular weight: C12H21NO8S 339.37
Characters: White or yellowish crystalline powder, melting point: 122 a 126A C.
Quality Standard: USP32, purity a Y 98.0%
TESTING SPECIFICATIONUSP 32
ITEM TESTEDSTANDARD
AppearanceWhite to off-white powder. Freely soluble in dichloromethane
IdentificationInfrared 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
Specific rotation Between -28.6A and -35.0A ,measured at 20A
WaterNot more than 0.5%
Residue on IgnitionNot more than 0.1%
Heavy metalsNot more than 10ppm
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 sulfateSulfamate 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.