Alpha Lipoic Acid

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Molecular Formula: C8H14O2S2 Molecular Weight: 206.33 Structural Formular : Character: Slightly yellow crystal or powder; Almost odorless, It dissolves difficult in water, but easily in alcohol, ether, and chloroform. Uses: Medicine of vitamin;Acute and chronic hepatitis, cirrhosis, hepatic coma, fatty liver, etc.
Appearance
Slightly yellow crystal powder almost ordeless
Conforms

Identification
Conforms
Conforms

Melting point
60ºC -62ºC
62ºC

Loss on drying
0.20% Max
0.18%

Residue on ignition
0.10% Max
0.06%

Specific rotation
-1.0º +1.0º
Conforms

Limit of polymer content
2.0% max
Conforms

Related Substances by HPLC

6,8-Epitrithleoctanolic acid(EPI)
0.10% Max
0.09%

Single impurities
0.10% Max
0.04%

Total Impurities
0.50% Max
0.30%

Residue by GC

Cyelohexane
1000 PPM Max
940 PPM

Ethyl acetate
250 PPM Max
180 PPM

Toluene
20 PPM Max
16 PPM

Total acrobes counts
1000cfu/g Max
100 cfu/g

Moulds and yeasts
100cfu/g Max
Less than 10 cfu/g

E.coli/Salmonella
Absence/g
Not detectable

Staphyloeaccus nureate
Absence/g
Not detectable

Particle size
100% through 40 mesh
conforms

Losse bulk density

0.279g/ml

Assay
99.0-101.0%
99.54%

Result: The product conform to USP28

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