Item | Specification |
Appearance | Slightly yellow crystalline powder |
Identification | Meets the requirements |
Melting point | 60.0~62.0℃ |
Specific rotation | -1.0° to +1.0c |
Loss on drying | ≤0.20% |
Residue on ignition | ≤0.10% |
Heavy Metals | ≤10ppm |
Lead | ≤3ppm |
Cadmium | ≤1ppm |
Mercury | ≤0.1ppm |
Chromatographic purity | |
Single impurity | ≤0.10% |
Total impurities | ≤2.0% |
Limit of polymer content | Conforms |
Residual solvent by GC | |
Cyclohexane | ≤3880ppm |
Ethyl acetate | ≤500ppm |
Total plate counts | ≤1000CFU/g |
Moulds and yeasts | ≤100CFU/g |
E.coli/Salmonella | Absence/g |
Staphylococcus aureus | Absence/g |
Particle size | 100% through 40 mesh |
Loose bulk density | 0.35g/ml min |
Assay | 99.0%~101.0% |