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
Tags :
Fusidic acid
Fusidine
6990-06-3
Fusidic acid China
Fusidic acid factory
Fusidic acid manufacturer
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