Model No.: USP
Appearance | Slight yellow crystal powder | |
Identification | Meet the requirements | |
Melting point | 60~62 ℃ | |
Heavy metals | 10 ppm Max | |
Lead | 3 ppm Max | |
Cadmium | 1 ppm Max | |
Mercury | 0.1 ppm Max | |
Loss on drying | 0.2% Max | |
Residue on ignition | 0.1% Max | |
Specific Rotation | -1.0°- +1.0° | |
Limit of polymer content | 2% Max | |
Related substance by HPLC | ||
6,8-Epitrithiooctanoic acid(EPI) | 0.10% Max | |
Single impurity | 0.10% Max | |
Total impurities | 0.50% Max | |
Residual Solvent by GC | ||
Cyclohexane | 1000ppm Max | |
Ethyl Acetate | 250ppm Max | |
Toluene | 20ppm Max | |
Total Plate Count | 1000 cfu/g Max | |
Moulds & Yeasts | 100cfu/g Max | |
E. coli/ Salmonella | Absence/g | |
Staphylococcus aureus | Absence/g | |
Particle Size | 100% through 40 mesh | |
Loose Bulk Density | / | |
Assay | 99%~101% |
Product Categories : API