items

standard

result

appearance

white crystalline powder

white crystalline powder

assay,hplc

98-101%

99.50%

purity

98%min

99.68%

specificoptical rotatio

-28.5°to -34.5°

-31.74°

melting point

110℃-114℃

110℃-113℃

solubility

soluble in water and methanol

soluble in water and methanol

identification by ir

the ir spectrum of the sample should be concordant with the working standard

confirm

absorbance 5% w/v solution in water

(a)300nm

(b)400nm

not more than 0.15

not more than 0.06

0.13

0.04

moisture content by kf

1.0%max

0.23%

1.4-dioxane

should be absent

n.d