Product Name: Sodium Fusidate

Expiry date: 2 Years

Items

Specifications

Appearance

White or almost white, crystalline powder, slightly hygroscopic

Solubility

Freely soluble in water and in ethanol (96 percent )

Identification A (IR)

The infrared spectrum should be conformed with the sodium fusidate CRS

Identification B

The residue gives reaction of sodium

Appearance of solution

The solution is not more intensely coloured than reference solution B6

PH

7.5~9.0

Impurity M

≤1.0%

Impurity G

≤0.7%

Impurity L

≤0.5%

Impurity B

≤0.4%

Impurity A

≤0.3%

Impurity H

≤0.1%

Impurity C

≤0.2%

Impurity D

≤0.2%

Impurity F

≤0.2%

Impurity I

≤0.2%

Impurity K

≤0.2%

Impurity N

≤0.2%

Main unspecified impurities

≤0.10%

Total impurities

≤2.0%

Water

≤2.0%

Content (anhydrous substance)

97.5%~101.0%

Residual solvent

Ethanol

≤5000ppm

Acetone

≤5000ppm

Conclusion

Conforms to the requirements of EP8.0