fluconazole
Standard:CP/BP/USP/EP
Product Description
Fluconazole is a medication used to treat fungal infections. It is a broad-spectrum antifungal drug that has therapeutic effects on both human and animal fungal infections
Product Details
Test | Standard | Results |
Appearance | White or Off-white,crystalline powder | White crystalline powder |
Identification 1 | The maximum and minimum uv absorption peaks of this product should be in the same range as the reference spectrum. | Conform |
Identification 2 | IR spectrum is accordance with the spectrum obtained with the RS. | Conform |
Clarity and color of solution | The solution is clear and colorless. | Conform |
Impurity A | ≤0.2% | 0.05% |
Impurity B | ≤0.1% | 0.03% |
Impurity C | ≤0.2% | N.D |
Specified impurity | ≤1.0% | 0.07% |
Any other individual impurity | ≤0.1% | 0.08% |
Total unknown impurities | ≤0.3% | 0.1% |
Total impurities | ≤1.5% | 0.33% |
Loss on drying | ≤0.5% | 0.1% |
Residue on ignition | ≤0.1% | 0.02% |
Heavy metals | ≤20ppm | Conform |
Assay | 98.0%~102.0%(Calculated on the dried basis) | 99.8% |
Conclusion | Complies with USP41 standard. |
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packing
FAQ
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