Appearance Almost white yellowish, crystalline powder,slight hygroscopic
Identification Conform
Specific optical rotation -155?-170?
Crysttallinity Conform
Clarity of solution Should be clarified
PH 6.0-8.0
Water 8.0-11.0%
Sterility Conform
N,N-Dimethylaniline 0.0020% max
2-Ethylhexyl acid 0.8% max
Single impurity 1.0% max
Total impurity 4.0% max
Bacteral endotoxins 0.08IU/mg max
Sub-visible particles 2250 particles/g max(10um min)
225 particles/g max(25um min)
Potency,dry base 96.0-102.0%
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