Item

Specification

Description

White crystal or white crystalline powder

Identification

The retention time of main peak is accordant with that of Benfotiamine RS

Melting point

≥198℃

Loss on drying

≤1.2%

Clarity and color of solution

Colorless to light yellow clear solution

Chloride

≤0.053%

Sulphate

≤0.011%

Heavy metals

≤20ppm

Cd

≤1ppm

As

≤1ppm

Pb

≤0.5ppm

Hg

≤0.3ppm

Bulk density

≥0.35g/ml

Related substances

Thiamine

≤0.1%

Benzoic acid

≤0.1%

Total impurities

≤1.0%

Assay

98.0%~102.0%

Microbe. Test:

Total Plate Count

≤1000CFU/g

Yeast & Mold

≤100CFU/g

Salmonella

Negative

E.Coli

Negative

Staphylococcus Aureus

Negative