Fusidic acid 6990-06-3

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Product Information

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
Identification	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.

Usage

The application of Fusidic acid:

Fusidic acid is primarily used as an antibiotic to treat bacterial infections. It is commonly applied topically, as a Fusidic acid cream or Fusidic acid ointment, to treat skin infections such as impetigo, infected cuts or wounds, and infected eczema. In some cases, it may also be prescribed orally or intravenously to treat systemic infections, particularly those caused by Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA).

Additionally, fusidic acid has been used in combination with other medications for the treatment of various infections. For example, it may be combined with corticosteroids to treat inflammatory skin conditions or with hydrocortisone to treat otitis externa (outer ear infections).

Fusidic acid works by inhibiting bacterial protein synthesis, specifically targeting the ribosomes within bacterial cells. This mechanism of action makes it effective against a wide range of bacteria, particularly Staphylococcus species. However, it is important to use fusidic acid judiciously to prevent the development of antibiotic resistance.

*Products under the patent are only for R&D use