 |
Item | Specifications | Results |
Assay (dry substance) | ≥99.0%~101.0% | 99.32% |
Identification | IR-Spectroscopy Liquid chromatography | Complies Complies |
Specific rotation | -1.0~+1.0° | Complies |
Melting range | 60.0~62.0℃ | 60.1~61.8℃ |
Loss on drying | ≤0.2% | 0.08% |
Residue on ignition | ≤0.1% | 0.05% |
Heavy metals | ≤0.001% | <0.001% |
Related substances(HPLC) | ||
6,8-Epitrithiooctanoic acid | ≤0.1% | 0.02% |
Any other impurity | ≤0.1% | Complies |
Total impurities | ≤0.3% | 0.10% |
Polymer | ≤2.0% | Complies |
Residual solvents(GC) | ||
Ethyl actetate | ≤5000ppm | 203 ppm |
Cyclohexane | ≤3380ppm | 1030 ppm |
Acetone | ≤500ppm | 2 ppm |
Toluene | ≤890ppm | Not Detectable |
Ethanol | ≤5000ppm | Not Detectable |
Benzene | ≤2ppm | Not Detectable |
Microbial contamination | ||
Total viable aerobic count (CFU/g) | ≤1000 CFU/g | Complies |
Yeasts & Molds (CFU/g) | ≤100 CFU/g | Complies |
Salmonella | Absent /g | Absent /g |
Escherichia Coli | Absent /g | Absent /g |
Staphylococcus aureate | Absent /g | Absent /g |
Pseudomonas aeruginosa | Absent /g | Absent /g |
Item | Specifications | Results |
Assay (dry substance) | ≥99.0%~101.0% | 99.32% |
Identification | IR-Spectroscopy Liquid chromatography | Complies Complies |
Specific rotation | -1.0~+1.0° | Complies |
Melting range | 60.0~62.0℃ | 60.1~61.8℃ |
Loss on drying | ≤0.2% | 0.08% |
Residue on ignition | ≤0.1% | 0.05% |
Heavy metals | ≤0.001% | <0.001% |
Related substances(HPLC) | ||
6,8-Epitrithiooctanoic acid | ≤0.1% | 0.02% |
Any other impurity | ≤0.1% | Complies |
Total impurities | ≤0.3% | 0.10% |
Polymer | ≤2.0% | Complies |
Residual solvents(GC) | ||
Ethyl actetate | ≤5000ppm | 203 ppm |
Cyclohexane | ≤3380ppm | 1030 ppm |
Acetone | ≤500ppm | 2 ppm |
Toluene | ≤890ppm | Not Detectable |
Ethanol | ≤5000ppm | Not Detectable |
Benzene | ≤2ppm | Not Detectable |
Microbial contamination | ||
Total viable aerobic count (CFU/g) | ≤1000 CFU/g | Complies |
Yeasts & Molds (CFU/g) | ≤100 CFU/g | Complies |
Salmonella | Absent /g | Absent /g |
Escherichia Coli | Absent /g | Absent /g |
Staphylococcus aureate | Absent /g | Absent /g |
Pseudomonas aeruginosa | Absent /g | Absent /g |
