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Sitagliptin Phosphate 654671-78-0/ 654671-77-9

Sitagliptin Phosphate 654671-78-0/ 654671-77-9

98.5% up by HPLC
  • Product Details

Product Information


Product name

Sitagliptin Phosphate

CAS No.

654671-78-0/ 654671-77-9

Molecular Formula

C16H18F6N5O5P

Molecular Weight

505.31

Quality Standard

98.5% up by HPLC

Appearance

White powder


COA of Sitagliptin Phosphate


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 Phosphate

Sitagliptin phosphate belongs to the class of Oral antihyperglycemic agents. For patients with type II diabetes, after taking it, it can improve blood sugar by increasing the level of active insulin-stimulating hormone, which can reduce fasting blood sugar, and can also play a role in regulating the level of postprandial blood sugar, so that blood sugar can be controlled at a stable level. status.


1. Monotherapy:

Sitagliptin phosphate, in combination with diet and exercise, is used to improve glycemic control in patients with type II diabetes.

2. In combination with metformin:

When metformin hydrochloride alone has poor glycemic control, sitagliptin phosphate can be used in combination with metformin hydrochloride to improve glycemic control in patients with type II diabetes on the basis of diet and exercise.

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