Sodium Fusidate
Sodium fusidate is often prescribed to treat bone infections caused by this bacterium. It works by stopping the growth of the bacteria. Sodium fusidate is also prescribed for other infections caused by staphylococcal bacteria, such as some skin infections.Sodium fusidate is a salt of a medicine called fusidic acid. You may find either of these names being given as the ingredient of Fucidin®, depending upon whether you are prescribed tablets or liquid medicine.Fusidic acid is also an ingredient of a skin cream and a skin ointment. These preparations are used to treat skin infections and more information is available about them in the separate medicine leaflet called Fusidic acid for skin infections.
Our Sodium Fusidate API Powder specification as below:
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Certificate Of Analysis
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Product Name
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Sodium Fusidate
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HS Code
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2942000000
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Batch No.
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20151211
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Sample Qty Base
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102.6KGS
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Date of Production
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2015.12.11
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Analysis Date
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2015.12.14
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Standard
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EP8.0&BP2012
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Expiry Date
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2018.12.10
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HS Code
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751-94-0
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Packaging
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5kgs/Tin&10kgs/Carton
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Item
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Standard
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Test Results
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Appearance
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White or almost white, crystalline powder, slightly hygroscopic.
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Complies
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Solubility
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Freely soluble in water and in ethanol (96 per cent).
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Complies
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Identification
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A.Infrared absorption spectrophotometry.
Comparison Ph. Eur. reference spectrum of fusidic acid.
B. Thin-layer chromatography.
C. Ignite 1 g. The residue gives reaction (a) of sodium
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Complies
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Appearance of
solution
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The solution is not more intensely coloured than reference solution B6.
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Complies
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pH
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7.5～9.0
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8.0
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Related substances
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Impurity M
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≤1.0%
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0.09%
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Impurity G
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≤0.7%
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Not Detect
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Impurity L
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≤0.5%
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Not Detect
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Impurity B
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≤0.4%
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Not Detect
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Impurity A
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≤0.3%
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Not Detect
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Impurity H
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≤0.1%
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0.04%
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Impurity C
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≤0.2%
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Not Detect
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Impurity D
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≤0.2%
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Not Detect
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Impurity F
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≤0.2%
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Not Detect
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Impurity I
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≤0.2%
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0.01%
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Impurity K
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≤0.2%
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0.03%
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Impurity N
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≤0.2%
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Not Detect
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Any other impurity
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≤0.1%
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Not Detect
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Total Impurity
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≤0.2%
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0.18%
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Water
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≤2.0%, determined on 0.50 g.
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0.4%
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Assay
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97.5% to 101.0% (anhydrous substance).
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100.1%
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Residual Solvents
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Ethanol
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≤5000 ppm
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1 ppm
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Acetone
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≤5000 ppm
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97ppm
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Conclusion
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The batch conforms to the EP8.0&BP2012 standard
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