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ALPHA LIPOIC ACID

Specifications


ITEMS

SPECIFICATIONS

Appearance

Yellow crystalline powder

Identification (HPLC)

Positive

Melting Point

60 – 62° C

Solubility (1N NaOH)

Clear & pale yellow

Residue on Ignition

0.10% Max.

Heavy Metals

10 ppm Max.

Chloride

0.10% Max.

Loss on Drying

0.20% Max.

Assay (HPLC)

99.0% - 101.0%

Specific Optical Rotation

-1° to +1°

Related Substances (HPLC):

 

Single Impurity

0.10% Max.

6,8-Epitrithiooctanoic Acid

0.10% Max.

Total Impurities

0.50% Max.

Polymer (TLC)

2.00% Max.

Residual Solvents (GC):

 

Toluene

30 ppm Max.

Ethylacetate

250 ppm Max.

Cyclohexane

0.20% Max.

Microbiology:

 

Total Plate Count

1,000 CFU/g Max.

Yeast & Mold

100 CFU/g Max.

E. Coli

Negative

Salmonella

Negative