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Items | Specification | |
Appearance | White or almost crystalline powder | |
Odor | Characteristic | |
Identification | Chemical method or IR or HPLC | |
E1cm1% | ≤0.05% | |
pH | 5.0~7.5 | |
Water content | ≤13.0% | |
Assay | 98.5%~102.0% | |
Calcium | 14.6%~15.13% | |
Related Substance | ||
Any single impurity | ≤0.5% | |
Total impurity | ≤1.0% | |
Residual solvents | ||
Methanol | ≤0.3% | |
Ether | ≤0.5% | |
Chloride | ≤0.02% | |
Heavy metals | ≤0.0020% | |
Lead | ≤3ppm | |
Mercury | ≤0.1ppm | |
Cadmium | ≤1ppm | |
Total Plate Count | ≤1000 Cfu/g | |
Yeast&Mold | ≤100 Cfu/g | |
E.Coli | Negative | |
Salmonella | Negative | |
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