Category:
Other Anti-Infective Drug
CAS NO:
6990-06-3
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Basic Info
CAS Number
6990-06-3
Pharmacopoeia
ChP,EP
Grade
Pharmaceutical Grade
Is Manufacturer
YES
Samples Provided
YES
Sample Policy
free sample
Packaging & Delivery
Packaging Specification
25kg/bag
Minimum Order Quantity
25kg
Delivery Cycle
7 days after payment
Product Description
|
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. |
|
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