98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9

Name: 98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9
Availability: 98-5-up-by-hplc-sitagliptin-phosphate-65-276191.html

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9
CAS No.:654671-78-0/ 654671-77-9
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

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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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98.5% up by HPLC Sitagliptin Phosphate 654671-78-0/ 654671-77-9

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

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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