Customization: | Available |
---|---|
Varieties: | Infectious Disease Prevention Medicine |
Component: | Microorganism |
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Audited by an independent third-party inspection agency
Items | Specifications | Analysis Results |
Appearance | Microcrystalline white powder | Conform |
Identification | A,B,C,D Corresponds | Conform |
Appearance of Solution | ≤BY5 | Conform |
Specific Optical Rotation | -0.10°~+0.10° | 0° |
Heavy Metals (Pb) | ≤10mg/kg | <10mg/kg |
Loss on Drying | ≤0.5% | 0.11% |
Sulphated Ash | ≤0.1% | 0.05% |
Related Substance | Single impurity≤0.5% | <0.5% |
Total impurties≤1.0% | 0.32% | |
Assay | 99.0%~101.0% | 99.68% |
Conclusion | All the test results conform to EP5 |
Items | Specifications | Analysis Results |
Appearance | White or yellowish crystal powder | Conform |
Identification | 1. Sodium flame should be obvious response 2. HPLC: The retention time obtained from the test solution corresponds to that obtained from the standard solution |
Conform |
PH | 5.5 ~ 7.5 | 6.5 |
Water | ≤5.0% | 2.3% |
Related Substance | ≤3.0% | 2.4% |
Color and clarity of solution | Clear and colorless . | Conform |
Content (Ceftiofur ) | ≥ 85.0% | 85.6% |
Conclusion | Complies with the requirements of enterprise (According to USP30) |
Items | Specifications | Results |
Identification | Yellow-brown or grayish granular | Conform |
Loss on drying | ≤10.0% | 3.55% |
Granularity | ≥95% Passed the 20 mesh crbble, ≤5% Passed the 80 mesh crbble |
Pass |
Percentage of monensin A activity in the monensin | ≥90% | 94.82% |
Percentage of monensin A activity pass monensin B activity in the monensin | ≥95% | 99.26% |
Assay | 400-440mg/g | 217.6mg/g |
Heavy metals | ≤20ppm | <20ppm |
Arsenic Salt | ≤2ppm | <2ppm |