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Test Items | Specification | Test Results |
---|---|---|
Description | Yellow crystalline powder | Yellow crystalline powder |
Completeness of solution | 2% of water solution for this product should clear | Complies |
Identification | Positive | Positive |
Water | 7.0%-9.0% | 0.082 |
Residue on ignition | ≤0.2% | 0.0005 |
Chromatographic purity | ≤0.5% | 0.005 |
Organic volatile impurities | Alcohol ≤5000ppm | 337ppm |
(C20H22ClN3O·2HCl) Assay(C20H22ClN3O·2HCl) | 97.0%- | 0.998 |
Microbial limit | Bacteria≤1000 CFU/g | 10 CFU/g |
Fungi≤100 CFU/g | 10 CFU/g | |
E. coli Should not be detected | Absent | |
Conclusion | The quality of the above commodity complies standard |