Topiramate

SKU : ANS006
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CAS number

97240-79-4

molecular formula

C12H21NO8S

standard

USP32

Package

25kg/drum
ITEMS LIMIT
Appearance White crystalline powder
Melting Point 1220C~1260C
Rotation Degree -28.60~-350
Identification HPLC
Shall comply with approved tests
IR
Concordant with the reference standard
Water ≤0.5%
Residue on ignition ≤0.2%
Heavy metals ≤10ppm
Related Compound(TLC) Total impurities
≤0.5%
Individual impurities
≤0.3%
Related Compound(HPLC) Total impurities
≤0.5%
Compound A
≤0.3%
Other Individual impurities
≤0.1%
Limit of sulfamate and sulfate ≤0.1%
N-hexane Max 290μ/g
Ethyl acetate Max 2500μ/g
Pyridine Max 100μ/g
Total bacterial Max 100UFC/g
Fungus and/or yeast Max 10UFC/g
Pathogens Search E. coil
P. aeruginosa
S. aureus
Salmonella
Assay 98.0-102.0%

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