Items

Specification

Results

Method

Appearance

Slight yellow crystal powder  

Conforms

Organoleptic

Identification

Meet the requirements

Conforms

HPLC

Melting point

60~62 °C

61.8°C

USP

Heavy metals

10 ppm Max

<10 ppm

USP

Lead

3 ppm Max

<3 ppm

USP

Cadmium

1 ppm Max

<1 ppm

USP

Mercury

0.1 ppm Max

<0.1 ppm

USP

Loss on drying

0.2% Max

0.14%

USP

Residue on ignition

0.1% Max

0.04%

USP

Specific Rotation 

-1.0°- +1.0°

0°

USP

Limit of polymer content

2% Max

<2.0%

TLC

Related substance by HPLC

6,8-Epitrithiooctanoic acid(EPI)

0.10% Max

0.02%

HPLC

Single impurity

0.10% Max

0.04%

HPLC

Total impurities

0.50% Max

0.06%

HPLC

Residual Solvent by GC

Cyclohexane

1000ppm Max

919ppm

GC

Ethyl Acetate

250ppm Max

78ppm

GC

Toluene

20ppm Max

Not detectable

GC

Total Plate Count

1000 cfu/g Max

<10cfu/g

USP

Moulds & Yeasts

100cfu/g Max

<10 cfu/g

USP

E. coli/ Salmonella

Absence/g

Not detectable

USP

Staphylococcus aureus

Absence/g

Not detectable

USP

Particle Size

100% through 40 mesh

Conforms

USP

Loose Bulk Density

/

0.262 g/ml

USP

Assay

99%~101%

99.37%

HPLC

Conclusion

Conformed USP32