Natural active ingredients Non-GMO material 90% stigmasterol CAS No.: 83-48-7 CAS NO.83-48-7

items

specifications

results

appearance

white powder

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%

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