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Alpha Lipoic Acid
| ITEMS | LIMIT |
| Product name | Alpha lipoic acid (Thioctic Acid) |
| Appearance | Yellowish crystalline powder |
| Identification(HPLC) | Meets the requirements |
| Melting point(B.P) | 60-62℃ |
| Solubility(1N NaOH) | Clear and pale yellow |
| Residue on Ignition | ≤0.10% |
| Heavy metals | ≤10 ppm |
| Chloride | ≤0.10% |
| Loss on drying (Vacuum 40℃ 3hr) | ≤0.20% |
| Assay(by HPLC,USP Method) | 99.0-101.0% |
| Specific optical rotation | -1 °~+1 ° |
| Related substance(by HPLC) | |
| Single Impurity | ≤0.10% |
| 6,8-Epitrithiooctanoic acid | ≤0.10% |
| Total Impurities | ≤0.50% |
| Polymers(by TLC) | ≤2.0% |
| Residual Solvents(by GC) | |
| Toluene | ≤30 ppm |
| Ethyl Acetate | ≤250 ppm |
| Cyclohexane | ≤0.20% |
| Microbiology | |
| Total aerobic counts | ≤1000 cfu/g |
| Mould & Yeast | ≤100 cfu/g |
| E.coil | Not detectable |
| Salmonellas | Not detectable |
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