Description-Almost white or yellowish, crystalline powder, slightly hygroscopic
Solubility -In water: FreelyMethanol: Very slight solubleEthanol: Sparingly soluble

Identification
A: Infrared absorption
B: Reaction of sodium

Appearance of the solution  Clear, nmt BY5 or BY5(c=12%)
PH 6.0-8.0
Specific optical rotation  -155 to -170
Water content 8.0_11.0%
Related substances Single impurity: Nmt1%Total impurities: Nmt4%
N, N-Dimethylanlline Nmt 20ppm
2-Ethylhexanoic acid Nmt0.8% m/m
Bacterial endotoxins Nmt0.20 I. U. /mg

Sterility  Sterile
Assay 96.0-102.0%with reference to the dried substance
Particulate matterSub visible particles
Nlt 10um nmt 6000Nlt 25um nmt 600With reference to 2g, EP2.9.19
Visible particles  SE≤ 9.5(with reference to 2g, DAC Test 5)