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Alpha Lipoic Acid | Batch Number | ALA-20220506 | |
CAS | 1077-28-7 | Quantity | 500kgs/20drums |
Chemical Name | 1,2-Dithiolane-3-valeric acid | Test Standard | USP43 |
Molecular Formula | C8H14O2S2 | Molecular Weight | 206.33 |
Items | Specification | Test Method |
Appearance | Light yellow crystalline powder | Organoleptic |
Identification | Positive | HPLC |
Melting point | 60.0~62.0 ºC | USP |
Specific rotation | -1.0°to +1.0° | USP |
Individual impurity | ≤0.10% | HPLC |
Total impurities | ≤2.0% | HPLC |
Limit of Polymer Content | Conforms to standard | TLC |
Loss on drying | ≤0.20% | USP |
Residue on ignition | ≤0.10% | USP |
Particle Size | ≥90%thru #40 mesh | USP |
Heavy Metals | ||
Total Heavy metals | ≤10.0ppm | USP |
Lead | ≤1.0ppm | ICP-MS |
Arsenic | ≤ 1.0 ppm | ICP-MS |
Cadmium | ≤1.0ppm | ICP-MS |
Mercury | ≤0.1ppm | ICP-MS |
Residual Solvent | ||
Cyclohexane | ≤3880ppm | USP |
Ethyl acetate | ≤500ppm | USP |
Toluene | ≤50ppm | USP |
Microbiology | ||
Total Plate Counts | ≤1,000cfu/g | USP |
Moulds and Yeasts | ≤100cfu/g | USP |
E.Coli | Negative/10g | USP |
Salmonella | Negative/25g | USP |
Staphylococcus aureus | Negative/10g | USP |
Assay | 98.5%-101.0% | HPLC |
Packing: N.W.:25kgs/drum, packed in double food grade plastic bags in fiber drum Storage: Clean & dry place. Do not be frozen. Keep away from straight light ans heat. Shelf life: 2years when properly stored | ||
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