|
Identification
|
Standardization
|
Result
|
|
Aspect
|
Light yellow powder
|
Confirms
|
|
Identification
|
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
|
Confirms
|
|
Specific optical rotation
|
-1.0°~+1.0°
|
0.6°
|
|
Melting point
|
60-62°C
|
61°C
|
|
Loss on drying
|
0.2% max.
|
0.19%
|
|
Bulk density
|
≥0.60 g/ml
|
Confirms
|
|
Polymer content
|
2% max.
|
Confirms
|
|
6-8-epitrithiooctanoic acid
|
0.2% max.
|
Non detectable
|
|
Heavy metals
|
≤10ppm
|
Confirms
|
|
Chloride
|
≤0.07%
|
Confirms
|
|
Limit of polymer content
|
≤2.0%
|
Confirms
|
|
Residual of Cyclohexane
|
≤500ppm
|
Confirms
|
|
Residual of Ethyl Acetate
|
≤250ppm
|
Confirms
|
|
Residual of Toluene
|
≤20ppm
|
Confirms
|