Description

Almost white or pale yellow, slightly pink, slightly hygroscopic crystalline powder

pale yellow

Solubility

Freely soluble in water and in anhydrous ethanol

complies

Identification

(1)IR Spectrum conforms with RS

Complies

(2)gives reaction of bromides

Complies

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

Complies

Solution is not more intensely colored than reference solution

Complies

pH

8.9~9.5

9.18

Specific optical rotation

+ 28.5°~ + 32.0°

+29.6°

Related substances

Individual known impurities (A, B, C)≤0.2%; (F, G, H)≤0.15%

A:0.03%; F: 0.08%; C0.087, H,B,G:not found(≤0.05%); 

Individual unknown impurity ≤0.1%

Complies

Total impurities ≤1.0%

<1%, Complies

Chlorides

&le;0.1%

0.05%

Residual solvents

Methylene chloride &le;600ppm

&le;390ppm

Methanol&le;3000ppm

1860ppm

Ethyl ether &le;5000ppm

&le;30ppm

MTBE &le;5000ppm

630ppm

Ethyl acetate&le;5000ppm

&le;30ppm

Heavy metals

&le;20ppm

Complies

Water

&le;4.5%

3.3%

Sulphated ash

&le;0.1%

0.05%

Endotoxins

&le;7EU/mg

<2EU/mg

Assay

99.0%~101.0%

99.4%

Conclusion

The material complies to specifications given above