Item

Specification

Description

Almost white or pale yellow, slightly hygroscopic crystalline powder

Solubility

Freely soluble in water and in anhydrous ethanol

Identification

(1)IR Spectrum conforms with RS

(2)gives reaction of bromides

Appearance of solution

Dissolve 0.10 g in carbon dioxide-free water R and dilute to 10 ml with the same solvent. Solution is clear

Solution is not more intensely colored than reference solution BY5

pH

pH8.9～9.5

Specific optical rotation

+ 28.5°～ + 32.0°

Related substances

Individual known impurities A≤0.2%；(B, C)≤0.3%；(D, E, F, G, H）≤0.1%

Individual unknown impurity ≤0.1%

Total impurities ≤1.5%

Chlorides

≤0.1%

Residual solvents

Methylene chloride ≤600ppm

Methanol≤3000ppm

Ethyl ether ≤5000ppm

MTBE ≤5000ppm

Ethyl acetate≤5000ppm

Heavy metals

≤10ppm

Water

≤4.0%

Sulphated ash

≤0.1%

Endotoxin

≤7EU/mg

Assay

99.0%～101.0%