Items

Specifications

Results

Appearance

Yellowish crystalline powder

Conforms

Identification

Conforms

Conforms

Melting Point

60~62℃

60~61.8℃

Heavy Metals

≤10ppm

<10ppm

Loss on drying

≤0.20%

0.05%

Residue on ignition

<0.10%

0.03%

Specific rotation

-1.0° ~ +1.0°

Conforms

Chromatographic Purity,

Procedure 1

Individual impurities ≤0.1%

0.07%

Total impurities ≤2.0%

0.15%

Chromatographic Purity,

Procedure 2

No spot other than Alpha Lipoic Acid spot from the sample solution is more intense than the spot at RF=0 from the standard solution A.

<0.2%

Residual Solvents

 (by GC)

Cyclohexane ≤0.20%

0.09%

Toluene ≤30ppm

≤20ppm

Microbiology

Total Aerobic count ≤1000 cfu/g

<100 cfu/g

Molds and yeasts ≤100 cfu/g

<10 cfu/g

E.coil: Not detected

Undetected

Salmonella: Not detected

Undetected

Assay (by HPLC)

99.0%~101.0%

99.4%

Conclusion

The product conforms to USP39 Specifications.