items

standards

results

appearance

white or almost white powder

almost white powder

solubility

slightly soluble in methanol

corresponds

melting point

163~168°c

164.0~165.5°c

specific rotation

+45~48°

+46.7°

identification

1) the ir absorption spectrum of the sample is concordant with that of voglibose reference standard

2) hplc

corresponds

acidity

9.4 ~10.4

9.8

related substances(hplc)

max. single impurity£0.5%;

total impurity:£1.0%

max. single impurity: 0.15%

total impurities: 0.18%

water

≤0.5%

0.06%

residue on ignition

≤0.2%

0.19%

heavy metals

≤10ppm

corresponds

assay

(on dried basis)

≥99.0%

99.5%

conclusion:

it complies with in-home standards