Product name

Fusidic acid;

Fusidine

CAS No.

6990-06-3

Molecular Formula

C31H48O6

Molecular Weight

516.719

Quality Standard

97.5% up by HPLC

Appearance

White or almost white, crystalline powder

COA

ANALYSIS

SPECIFICATION

RESULTS

Appearance

White or almost white, crystalline powder

White crystalline powder

Solubility

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

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

Identification

IR: IR absorption spectrum of sample is in identical with that of reference substance

IR absorption spectrum of sample is in identical with that of reference substance

Reaction of sodium:  The residue does not give reaction (a) of sodium

The residue does not give reaction (a) of sodium

Water

1.4%-2.0%

1.7%

Sulfated ash

≤0.2%

0.1%

Assay

(on anhydrous basis)

97.5% - 101.0%

99.9%

Particle size

90% Particle diamite < 20 μm

100% Particle diamite < 20 μm

Related substance

Impurity M ≤ 1.0%

0.1%

Impurity G ≤ 0.7%

Not detected

Impurity L ≤ 0.5%

Not detected

Impurity B ≤ 0.4%

Not detected

Impurity A ≤ 0.3%

Not detected

Impurity H ≤ 0.10%

Not detected

Impurity C ≤ 0.2%

Not detected

Impurity D ≤ 0.2%

Not detected

Impurity F ≤ 0.2%

Not detected

Impurity I  ≤ 0.2%

Not detected

Impurity K ≤ 0.2%

Not detected

Impurity K ≤ 0.2%

Not detected

Max unknown impurity ≤ 0.10%

Not detected

Total impurities ≤ 2.0%

0.1%

Residual solvents

Ethanol ≤ 5000pm

Not detected

Methanol ≤ 3000pm

Not detected

Ethyl acetate ≤ 5000pm

Not detected

N-hexane ≤ 290pm

Not detected

Microbial limit

Bacteria ≤ 100cfu/g

Not detected

Total molds and yeasts ≤ 10cfu/g

Not detected

Staphylococcus aureus: None

Not detected

Pseudomonas aeruginosa: None

Not detected

Conclusion

The sample complies with EP.