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 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