Sitagliptin is an oral antihyperglycemic of the dipeptidyl peptidase-4 inhibitor class. This enzyme-inhibiting drug is used either alone or in combination with other oral antihyperglycemic agents for treatment of diabetes mellitus type 2.The benefit of this medicine is its fewer side effects in the control of blood glucose values. While safety is its advantage, efficacy is often challenged as it is often recommended to be combined with other agents such as metformin.
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that controls blood glucose levels by protecting and enhancing endogenous enteroglycin.Glucose-dependent insulin-releasing peptides (GIP) and glucagon-like peptide-1 (GLP-1) are enteroglycins released in response to dietary intake.
GLP-1 and GIP can increase insulin synthesis and release from islet β cells through intracellular signaling pathways. GLP-1 can also reduce glucagon secretion from islet α cells and reduce hepatic glucose production.However, both GLP-1 and GIP are rapidly metabolized by DPP-4, resulting in the loss of their insulin-promoting effect.
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Item | Test Standard | Testing Result | |
CBD | Not less than (NLT) 99.5% 99.9% | ||
THC | Not detected | Undetected | |
Assay | Method HPLC calculated on the anhydrous basis limit of quotation (LOQ) 0.8ppm | ||
Appearance | White powder | White powder | |
Identification | In the recorded chromatograms under the determination of the substance, retention time of the main peak of the solution should be consistent with the retention of time of the main peak of the reference solution | Complies | |
Melting Point | 65~66ºC | 65.5ºC | |
Loss on Drying | NMT 1.0% | 0.21% | |
Residual solvents | Ethanol NMT 400ppm Heptane NMT 400ppm |
1.92ppm 256.0ppm |
|
Heavy Mental | NMT 20ppm | Complies | |
Microbial Limite Test | Method: Plate Counting | ||
Total aerobic bacteria count | NMT 1000cfu/g | Complies | |
Combined molds and yeast | NMT 100cfu/g | Complies | |
E. Coli | Not detacted per gram | Complies | |
Salmanella | Not detacted per 10 gram | Complies | |
Conclusion: Conform the testing result is qualified |
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