Sodium fusidate
CAS No.: 751-94-0
Other Names: Fusidic acid sodium salt
MF: C31H47NaO6
Name: Sodium fusidate
CAS No.: 751-94-0
Other Names: Fusidic acid sodium salt
MF: C31H47NaO6
Specifications
A white or almost white Crystalline powder
Appearance
A white or almost white Crystalline powder
Solubility
Practically insoluble in water,
Freely soluble in alcohol
Identification
IR-spectrum; TLC
Related substances(HPLC)
Not More Than 2.0%
water (K.Fisher)
1.4%-2.0%
Sulfated ash
Not more than 0.2%
Assay
97.5-101.0% calculated to
anhydrous substance
Residual solvents
Methanol n.m.t 0.3%
Butyl acetate n.m.t 0.1%
Butanol n.m.t 0.05%
Biological
Not less than 900U/mg,
Calculated with reference to the
Anhydrous substance
water (K.Fisher)
1.4%-2.0%
Test items | Specifications | Results | ||
Description | White or yellowish-white crystalline powder | Yellowish-white crystalline powder | ||
Identification | Positive | Meets | ||
Melting point | About 198°C | 196.8°C~197.8°C | ||
Clarity | ≤1FTU | Meets | ||
Solution | ≤Y5,BY5 or GY5 | less than BY5 | ||
Acidity | ≤0.2ml/g | less than 0.18ml/g | ||
Related substances | ≤0.5% | less than 0.4% | ||
Heavy metals | ≤20ppm | less than20ppm | ||
4.6-dichloro-5-methoxypyridine | ≤0.014% | less than 0.014% | ||
Loss on drying | ≤0.5% | 0.24% | ||
Sulphated ash | ≤0.1% | 0.06% | ||
Assay(the dried aubstance) | 99.0%-101.0% | 99.67% |