The retention time of the peak for alpha lipoic acid in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation,as obtained in the Assay。
Solubility(In NaOH)
Clear and pale yellow
Melting Point
60~62℃
Heavy Metals
10ppm max
Loss on drying
0.20% max
Residue on Ignition
0.10% max
Chloride
0.07% max
Specific rotation
-1.0°to +1.0°
Limit of polymer content
2.0% max
Related Substance By HPLC
6.8-Epitrithlooctanolic acid(EPI)
0.10% max
Single Impurity
0.10% max
Total Imurities
0.50% max
Residual Slovene By GC
Cyclohexane
500ppm max
Ethyl Acetate
250ppm max
Toluene
20ppm max
Total aerobes counts
1000 CFU/g
Moulds and Yeasts
100 CFU/g
E.coli/Salmonella
Absence/g
Staphylococcus aureate
Absence/g
Particle Size
100% through 20 mesh
20% max. through 100 mesh
Bulk Density
0.30 g/ml
Assay
99%~101%
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