Tests | Results | Specifications | ||
Melting point | 60.7ºC-61.3ºC | Should be 60ºC-62ºC | ||
Optical rotation | 0° | Should be -1°- +1° | ||
Identification | Complies | HPLC | ||
Complies | IR | |||
Polymeric Lipoic Acid | Conforms | NMT 1.0% | ||
Related substances | 0.08% | Max Individual Impurity: NMT 0.1% | ||
0.08% | Total Impurity: NMT 2.0% | |||
Residual Solvents | 0.18% | Cyc lohexane: NMT 0.388% | ||
N. D | Ethyl Ace tate: NMT 0.5% | |||
N. D | Tol uene: 0.089% | |||
Loss on drying | 0.1% | NMT 0.2% | ||
Residue on ignition | 0.04% | NMT 0.1% | ||
Heavy metals | ≤10ppm | ≤10ppm | ||
Assay | 99.96% | NLT 99.0% NMT101.0% (calculated on the dried basis) | ||
Conclusion: Conforms to USP43 standard . |