Product Name: Fusidic Acid

Expiry Date: 2 Years

Items

Specifications

Appearance

White or almost white, crystalline powder

Solubility

Practically insoluble in water, freely soluble in ethanol (96 percent)

Identification

The infrared spectrum should be conformed with the fusidic acid CRS

The residue does not give reaction of sodium

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

1.4%~2.0%

Sulfated ash

≤0.2%

Content (anhydrous substance )

97.5%~101.0%

Residual solvents

Ethanol

≤5000ppm

Methanol

≤3000ppm

Ethyl acetate

≤5000ppm

N-hexane

≤290ppm

Conclusion

Conforms to the requirements of EP8.0