Alpha Lipoic Acid
Ville: LV, Marupe
Physical & Chemical Characteristics
Analysis Item | Specification | Result |
Appearance | Yellow crystalline powder | Complies |
Identification | IR-Spectroscopy | Conforms |
Identification | Liquid chromatography | Conforms |
Melting Point | 60.0~62.0℃ | 61.8℃ |
Specific Rotation | -1.0° to +1.0° | 0° |
Particle Size Loose | 100% through 40 mesh | Conforms |
Bulk Density Assay | Report only | 0.42 g/ml |
Assay (dried basis) | 99.0% ~101.0% | 99.1% |
Heavy Metals
Analysis Item | Specification | Result |
Heavy Metals | Not more than 10ppm | Complies |
Lead | Not more than 3ppm | <3 ppm |
Arsenic | Not more than 1ppm | <1 ppm |
Cadmium | Not more than 1ppm | <1 ppm |
Mercury | Not more than 0,1ppm | <0.1 ppm |
Impurities
Analysis Item | Specification | Result |
Loss on Drying | Not more than 0.20% | 0.08% |
Residue on Ignition | Not more than 0.10% | 0.02% |
Individual Impurities | 0.10% max | 0.02% |
Total Impurities | 2.0% max | 0.04% |
Chromatographic Purity | Conforms | Conforms |
Residual Solvents
Analysis Item | Specification | Result |
Cyclohexane | 3880 ppm max | 1510 ppm |
Ethyl Acetate | 500 ppm max | 110 ppm |
Toluene | 20 ppm max | 10 ppm |
Microbiological Tests
Analysis Item | Specification | Result |
Total Plate Count | ≤1000 CFU/g | <10 CFU/g |
Yeast & Mold | ≤100 CFU/g | <10 CFU/g |
E. Coli | Absence/g | Not Detected |
Staphylococcus aureus | Absence/g | Not Detected |
Salmonella | Absence/g | Not Detected |