Varieties: | Other |
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Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
Customization: |
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Items | Standard | Test Result |
Appearance | White or almost white crystalline powder | White crystalline powder |
Identification | ||
A. Infrared absorption | The infrared absorption spectrum is concordant with the reference spectrum | Conform |
B. Ultraviolet Absorption | Absorptivities at 272nm, calculated on the dried base, do not differ by more than 3% | 1% |
Specific rotation | -17.0°~-15.3° | -16.8° |
Loss on drying | ≤1.0% | 0.2% |
Heavy metals | ≤0.002% | <0.002% |
Free Naproxen | ≤1.0% | 0.1% |
Related substances(HPLC) | ||
Impurity D(in-house) | ≤0.10% | <0.01% |
Impurity E(in-house, impurity C in EP) | ≤0.10% | <0.01% |
Any other impurity | ≤0.10% | <0.01% |
Total impurities | ≤0.5% | <0.01% |
Residual solvents | ||
Toluene | ≤50ppm | <1ppm |
Methanol | ≤50ppm | <4ppm |
Assay(on dry basis) | 98.5%~101.5% | 100.4% |
Conclusion | The results conform with USP38. |
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