Fusidic Acid

Fusidic Acid

Details
EP and USP Standard
1.Synonym:Fusidine
2.Appearance:off-white crystal powder
3.Specification: ≥99%
4.CAS No.:6990-06-3
5.Molecular Formula:C31H48O6
6.Product Grade:Pharmaceutical grade
7.Certificates: FDA,Kosher,ISO, HALAL, HACCP, GMP
8.MOQ:0.1-1 KG
9.OEM ODM Available
Category
Active Pharmaceutical Ingredients
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Description
Technical Parameters

fucidin cream

Fusidic acid is a bacterial protein synthesis inhibitor. This product has been widely used in foreign clinical practice for nearly 60 years. It is mainly used to treat skin infections caused by Propionibacterium acnes, Staphylococcus, Streptococcus and other bacteria sensitive to fusidic acid.
Fucidin 2% cream was first approved for marketing in Denmark in 1962 and in the UK in 1979. It was later approved for marketing in Ireland, the Netherlands, France, Germany and other European countries as well as many other countries in the world.

fucidin cream

Items

Specification Results
Ref Standard EP9.0  

Characters

White or almost white crystalline powder

White crystalline powder

Solublity

Practically insoluble in water,freely soluble in

ethanol (96%)

Conformed

Identification

The infrared spectrum should be comformed with the fusidic acid CRS,the residue does not give reaction of sodium

Conformed

Impurity M

≤1.0%

0.22%

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 l

≤0.2%

None

Impurity K

≤0.2%

None

Impurity N

≤0.2%

None

Unspecificated impurity

≤0.1%

None

Total impurities

≤2.0%

0.22%

Water

1.4%~ 2.0%

1.78%

Sulfatedash

≤0.2%

0.05%

Assay(anhydroussubstance)

97.5%~101.0%

99.7%

Residual solvents

   

Ethanol

≤5000ppm

Con formed

Methanol

≤3000ppm

Conformed

Ethylacetate

≤5000ppm

Conformed

N-hexane

≤290ppm

Conformed

Conclusion: The product conforms to standard of EP9.0

fucidin cream

1. The main function of fusidic acid is antibacterial, which can inhibit the synthesis of bacterial proteins.
Fusidic acid binds to factor G (EF-G) to prevent the release of EF-G diphosphate guanosine complex, thereby inhibiting protein synthesis.
It is used for infected skin and soft tissue, surgical and traumatic infections, etc.
For normal skin, the amount of fusidic acid penetrating into the deep layer of the skin is very low. However, for infected skin, fusidic acid easily penetrates into the deep layer and enters the infected lesion.

2. Anti-acne and anti-inflammatory effects. Fusidic acid is highly sensitive to Propionibacterium acnes.

And this product is not easy to develop drug resistance. It is currently one of the main drugs for the treatment of acne.

fusidic acid powder

fucidin cream

In addition to creams, fusidic acid is available in a variety of other dosage forms.

1. Fucidin cream/fusidic acid cream:  antibiotic cream for skin infection.Apply to the affected area 2-3 times a day. The general course of treatment is 7 days.

2. Fusidic acid gel.

3. Sodium fusidate ointment.

Reference

[1]. Castanheira M, Watters AA, Bell JM, Turnidge JD, Jones RN (September 2010). "Fusidic acid resistance rates and prevalence of resistance mechanisms among Staphylococcus spp. isolated in North America and Australia, 2007-2008". Antimicrobial Agents and Chemotherapy. 54 (9): 3614–3617. doi:10.1128/AAC.01390-09. PMC 2934946. PMID 20566766.

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