Sinoway Industrial Co., Ltd.

Fosfato de sitagliptina 654671-78-0 / 654671-77-9 Fosfato de sitagliptina 654671-78-0 / 654671-77-9

Fosfato de sitagliptina 654671-78-0 / 654671-77-9
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Informação básica do Fosfato de Sitagliptina 654671-78-0 / 654671-77-9

Name

Sitagliptin

Molecular Formula

C16H15F6N5O

Molecular Weight

407.32

Quality Standard

In house

Package Size

1kg/bag or according your requirement

Brief Introduction

This drug 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.

Uso de Fosfato de Sitagliptina 654671-78-0 / 654671-77-9

  • Droga antidiabética no tratamento do diabetes tipo 2.

COA de fosfato de sitagliptina 654671-78-0 / 654671-77-9

ITEMS

STANDARDS

RESULTS

Appearance

White or off-white crystalline powder

Complies

Identification

A. Sitagliptin phosphate in water display discriminate reaction of phosphate.

B. HPLC: RRTtest solution is similar to RRTreference 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 toenterprise standard


MORE_DETAIL Fosfato de sitagliptina 654671-78-0 / 654671-77-9

Informação básica do Fosfato de Sitagliptina 654671-78-0 / 654671-77-9

Name

Sitagliptin

Molecular Formula

C16H15F6N5O

Molecular Weight

407.32

Quality Standard

In house

Package Size

1kg/bag or according your requirement

Brief Introduction

This drug 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.

Uso de Fosfato de Sitagliptina 654671-78-0 / 654671-77-9

  • Droga antidiabética no tratamento do diabetes tipo 2.

COA de fosfato de sitagliptina 654671-78-0 / 654671-77-9

ITEMS

STANDARDS

RESULTS

Appearance

White or off-white crystalline powder

Complies

Identification

A. Sitagliptin phosphate in water display discriminate reaction of phosphate.

B. HPLC: RRTtest solution is similar to RRTreference 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 toenterprise standard

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