Granular α-Lipoic Acid
Brief Introduction:
Alpha Lipoic Acid(α-Lipoic Acid) is a light yellow powder crystal, almost odorless. The solubility in water is small, about 1 g/L (20°C). But it is soluble in 10% NaOH solution and soluble in aliphatic solvents. It is also easily soluble in methanol, ethanol, chloroform and ether.
Specifications of our Alpha Lipoic Acid(Ordinary Granules):
| Test Items | Specifications | Test Methods | |
| Description | Slightly yellow granules | Organoleptic | |
| Identification | Meets the requirements | HPLC | |
| Melting Point | 60℃ ~ 62℃ | USP | |
| Loss on Drying | Not more than 0.2% | USP | |
| Residue on Ignition | Not more than 0.1% | USP | |
| Specific Rotation | -1.0° ~ +1.0° | USP | |
| Particle Size | 100% pass through 20 mesh sieve | USP | |
| Limit of polymer content | Meets the requirements | TLC | |
| Assay | 98.5% ~ 101.0% | HPLC | |
| Related Substances | Single Impurity | Not more than 0.10% | HPLC |
| Total Impurities | Not more than 2.0% | HPLC | |
| Bulk Density | / | USP | |
| Residual Solvents | Cyclohexane | Not more than 1000ppm | GC |
| Ethyl Acetate | Not more than 250ppm | GC | |
| Toluene | Not more than 20ppm | GC | |
| Heavy Metals | Lead(Pb) | Not more than 3ppm | USP |
| Arsenic(As) | Not more than 1ppm | USP | |
| Cadmium(Cd) | Not more than 1ppm | USP | |
| Mercury(Hg) | Not more than 0.1ppm | USP | |
| Microbial Test | Total Plate Count | Not more than 1000CFU/g | USP |
| Yeasts & Moulds | Not more than 100CFU/g | USP | |
| Escherichia coli | Negative/g | USP | |
| Salmonella | Negative/g | USP | |
| Staphylococcus aureus | Negative/g | USP | |
Instructions for Use:
Vitamin drugs are used for the treatment and curative effect of acute and chronic hepatitis, liver cirrhosis, hepatic coma, fatty liver, diabetes and other diseases.
Packaging:
25kg net drum or according to the requirements from customers.
Storage & Transportation:
Preserved in unopened original containers in a cool dry place before using, kept away from direct sunlight, heat and moisture; prevented from rain, strong acids or alkalis. Handle with care during transportation to prevent damage to the packages.
Shelf Life:
24 months if stored under above conditions.
