Product Information |
Product name |
Sitagliptin |
Molecular Formula |
C16H15F6N5O |
Molecular Weight |
407.32 |
CAS No. |
486460-32-6 |
Quality Standard |
98.9% up, medical grade |
Appearance |
White powder |
COA of Sitagliptin |
ITEMS |
STANDARDS |
RESULTS |
Appearance |
White or off-white crystalline powder |
Complies |
Identification |
A. Sitagliptin phosphate in water display discriminate reaction of phosphate. B. HPLC: RRT test solution is similar to RRT reference solution. C. IR: Similar to Reference Substance |
Complies
Complies
Complies
|
Related substance |
XG-E ≤0.15% |
N.D. |
XG-F ≤0.15% |
N.D. |
|
XG-G ≤0.15% |
N.D. |
|
XG-H ≤0.15% |
N.D. |
|
XG-K ≤0.15% |
N.D. |
|
XG-L ≤0.15% |
0.01% |
|
XG-M ≤0.15% |
N.D. |
|
XG-N ≤0.15% |
N.D. |
|
Other individual impurity ≤0.10% |
N.D. |
|
Total impurities ≤0.5% |
0.01% |
|
Isomer |
XG-A ≤0.15% |
N.D. |
Water |
3.0%~4.5% |
3.6% |
Residual solvents |
Isopropyl alcohol ≤0.5% |
0.02% |
Methyl tert-bytyl ether ≤0.5% |
N.D. |
|
Acetoacetate ≤0.5% |
N.D. |
|
Dimethylformamide ≤0.088% |
N.D. |
|
Heavy metals |
≤ 10ppm |
Complies |
Assay |
≥98.5% on anhydrous basis |
100.3% |
Conclusion |
Conforms to enterprise standard |
Usage |
Function of Sitagliptin
Sitagliptin is for dipeptide peptidase 4 (DPP - 4) depressants, by protecting endogenous im fall blood sugar, and enhance its role and control blood sugar levels. Glucose dependence on promoting insulin releasing peptide (GIP) and glucagon peptide 1 (glp-1), as for dietary intake and release of intestinal fall blood sugar.
4 randomized, placebo-controlled trials involving more than 2,000 type 2
diabetes patients evaluated the effect and safety of sitagliptin alone or in
combination with other hypoglycemic drugs Sex. The evaluation index is mainly
the change value of glycosylated hemoglobin (HbA1c) from the baseline. HbA1c is
an indicator of the average blood glucose level in the past 3-4 months.
Sitagliptin (100 or 200 mg) alone significantly reduced HbA1c levels. The
reduction in HbA1c levels was proportional to the initial level of HbA1c. There
was no increase in patient weight during the 24 weeks of single treatment.
Sitagliptin reduces fasting and postprandial blood sugar, increases the ratio
of preproinsulin/insulin, and improves insulin resistance.
For patients with at least 1500 mg of metformin a day that still cannot control blood sugar well, sitagliptin 100 mg was added. 47% of patients reached the target of HbA1C <7%, while only 18.3% of patients who received placebo achieved the target. Compared with the placebo group, HbA1C in the sitagliptin group decreased by 0.65% on average. The combination of Sitagliptin and metformin has also been shown to be effective as an initial treatment. Patients who were treated with pioglitazone and could not reach the goal (mean HbA1C level was 8.1%) were added sitagliptin 100mg, and the average HbA1C level of patients was reduced by 0.7%. Compared with the pioglitazone alone treatment group, a higher proportion of patients reached HbA1C<7% aims.
*Products under the patent are only for R&D use