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Benfotiamine is mainly used in the treatment of diabetic complications. Benfotiamine alleviates diabetic complications (such as neuropathy, nephropathy, and retinopathy) by inhibiting the formation of advanced glycation end products (AGE). Benfotiamine increases TPP in tissues, which enhances the activity of transketolases to reduce AGE in tissues and ultimately inhibit the progression of diabetic complications. The effects of benfotiamine also include improving diabetic myocardial contractility, reducing neuropathic pain and improving ventricular dysfunction after ischemia.
ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White crystal or white crystalline powder | Conform |
Identification | The retention time of main peak is accordant with that of Benfotiamine RS | Conform |
Melting point | ≥198℃ | 203~206℃ |
Loss on drying | ≤1.2% | 0.4% |
Clarity and color of solution | Colorless to light yellow clear solution | Colorless and clear solution |
Chloride | ≤0.053% | <0.053% |
Sulphate | ≤0.011% | <0.011% |
Heavy metals | ≤20ppm | <20ppm |
Cd | ≤1ppm | 0.042ppm |
As | ≤1ppm | <0.01ppm |
Pb | ≤0.5ppm | <0.02ppm |
Hg | ≤0.3ppm | <0.005ppm |
Bulk density | ≥0.35g/ml | 0.50g/ml |
Related substances | Thiamine ≤0.1% | 0.09% |
Benzoic acid ≤0.1% | 0.01% | |
Total impurities ≤1.0% | 0.3% | |
Microbe. Test: | Total Plate Count ≤1000CFU/g | <10CFU/g |
Yeast & Mold≤100CFU/g | <10CFU/g | |
Salmonella Negative | Negative | |
E.Coli Negative | Negative | |
StaphylococcusAureus | Negative | |
Assay | 98.0%~ 102.0% | 100.8% |
Conclusion | QUALIFIED. |
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