Product name: | Alpha Lipoic Acid | ||
CAS No: | 1077-28-7 | Batch Number: | RW-ALA20231122 |
Batch Quantity: | 1000 kgs | Manufacture Date : | Nov . 22 . 2023 |
Report Date : | Nov . 26. 20 21 | Expire Date : | Nov . 21. 20 2 3 |
Storage Condition: | Preserve in tight containers at controlled room temperature. | ||
I TEMS | S PECIFICATION | METHOD | TEST R ESULT |
Organoleptic | |||
Color | Yellow | Visual | Conforms |
Taste | Characteristic | Organoleptic | Conforms |
Odor | Characteristic | Organoleptic | Conforms |
Appearance | Powder | Visual | Conforms |
Analytical Quality | |||
Identification | IR, HPLC | Conforms | |
Assay | NLT 99.0%, NMT 101.0% | USP43 | 99.50% |
Polymeric Lipoic Acid | NMT 1 % | USP43 | Conforms |
Related Substance | Max Individual Impurity: NMT 0.1% | USP43 | 0.03% |
Total Impurity: NMT 2% | USP43 | 0.06% | |
Loss on Drying | NMT 0.2 % | USP43 | 0.04 % |
Residue on Ignition | NMT 0.1 % | USP43 | 0.02 % |
Residual Solvents | Cyclohexae: NMT 0.388% | USP43 | 0 . 16 % |
Ethyl Acetat: NMT 0.5% | USP43 | N.D | |
Toluen: NMT 0.089% | USP43 | N.D | |
Melting Point | 60ºC~62ºC | USP43 | 60.0ºC~61.5ºC |
Optical Rotation | -1°~+1° | USP43 | 0° |
Microb e Tests | |||
Total Yeast & Mold | NMT 1 0 0 cfu/g | <10 cfu/g | |
E.Coli | Negative | N.D | |
Aerobic Bacteria | NMT 1 0 0 0cfu/g | <10 cfu/g | |
Conclusion: | The sample meet USP43. | ||
Packing & Storage: | Package in cardboard-drums and plastic-bags inside. | ||
N.W: 25kgs/drum, 5kg/bag | |||
Store in a well-closed container away from moisture, light and oxygen. | |||
Shelf Life: | 24 months under the conditions above and in its original packaging. |
TEST ITEMS | SPECIFICATION | RESULTS |
Description | : Crystalline Powder | White Powder |
Identification | : Positive | Positive |
Assay(by HPLC) | : 98.0~102.0% | 99.34% |
Absorbance(E1cm) | : 465~495 | 482.5 |
Melting Point | : 191~195°C | 193.5~195.0°C |
Loss On Drying | : 0.5%max | 0.19% |
Specific Rotation | : +288°~ +298° | +290.2° |
Residue On Ignition | : 0.1%max | 0.03% |
Related Substances | : Total:1.5%max | <1.3% |
Single:0.5%max | <0.4% | |
Residue Solvents | : 0.2%max | 0.10% |
Heavy Metals | : 20PPm max | <10PPm |
Conclusion | The specification conform with enterprise standard. |
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