Uses:
Benfotiamine is a lipid-soluble derivative of thiamine, with higher bioavailability than thiamine itself. However, benfotiamine must be dephosphorylated by alkaline phosphatase to become a lipid-soluble precursor before it can cross cell membranes and exert its biological effects. Clinically, it is mainly used to treat diabetic complications, particularly for the treatment and prevention of diabetic retinopathy. Compared to other thiamine derivatives, this product is absorbed more rapidly and completely after oral administration. After being absorbed into the systemic circulation, benfotiamine is rapidly metabolized to thiamine without increasing the drug concentration in the brain. It also generates hippuric acid and is excreted in the urine.
Items
Standard
Appearance
White
crystal or white crystalline powder
Identification
The retention time of main peak is
accordant with that of Benfotiamine RS.
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
≤3ppm
Hg
≤0.3pp
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
Less ...