Product Name :

Fusidic Acid  

Batch Size:

50.00kg

Batch No:

20221015

Mfg.Date:

2022.10.15

Retest Date:

2024.10

Report Date:

2022.10.15

TESTS

Specifications

Results

Appearance

White or almost white crystalline powder

Conforms

Solubility

Practically insoluble in water;freely soluble in ethanol(96%)

Conforms

Identification A(IR)

The infrared spectrum should be conformed with the Fusidic Acid CRS

Conforms

Identification B

(The reaction of sodium)

The residue does not give reaction of sodium

Conforms

Impurity M

≤1.0%

0.1%

Impurity G

≤0.7%

None

Impurity L

≤0.5%

None

Impurity B

≤0.4%

None

Impurity A

≤0.3%

None

Impurity H

≤0.1%

None

Impurity C

≤0.2%

None

Impurity D

≤0.2%

None

Impurity F

≤0.2%

None

Impurity I

≤0.2%

None

Impurity K

≤0.2%

0.0%

Impurity N

≤0.2%

None

Main unspecified impurities

≤0.10%

None

Total impulse

≤2.0%

0.1%

Water

1.4%~2.0%

1.5%

Sulfated ash

≤0.2%

0.0%

Content(anhydrous substance)

97.5%~101.0%

99.43%

Residual

solvents

Ethanol

≤5000ppm

Conforms

Methanol

≤3000ppm

Ethylacetate

≤5000ppm

N-hexane

≤290ppm

Particle diamite ＜20um

Particle diamite ＜30um

＞90%

100%

98%

100%

Conclusion：Complies with EP 9.0