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Sitagliptin 486460-32-6

Sitagliptin 486460-32-6

98.5% up, Medical Grade
  • Product Details

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.

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Send A Message
Send A Message
If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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