Topiramate

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0 Metric Ton	Negotiable

0 Metric Ton

Negotiable

Topiramate
White to off-white powder
CAS: 97240-79-4
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1. Product Name: Topiramate

3. Chemical Name: 2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate

other name: McN-4853; RWJ-17021; Topamax

4. CAS RN: 97240-79-4

5. Structural Formula:

6. Molecular formula & Molecular weight: C₁₂H₂₁NO₈S 339.37

7. Characters: White or yellowish crystalline powder, melting point: 122 – 126°C.

8. Quality Standard: USP32, purity ≥ 98.0%

TESTING SPECIFICATION	USP 32
ITEM TESTED	STANDARD
Appearance	White to off-white powder. Freely soluble in dichloromethane
Identification	Infrared Absorption
Identification	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 -28.6° and -35.0°,measured at 20°
Water	Not more than 0.5%
Residue on Ignition	Not more than 0.1%
Heavy metals	Not 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 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.