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Dapagliflozin 461432-26-8 Dapagliflozin 461432-26-8

Dapagliflozin 461432-26-8
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Basic information of Dapagliflozin:

Name

Dapagliflozin

Alias

Bms 512148; BMS5121458; DAPAGLIFLOZIN;B MS-512148-05; Dag coluMn net; Dapagliflozin, >=98%; Dapagliflozin(BMS-512148); Dapagliflozin propanediol; Dapagliflozin Isomer Impurity; Dapagliflozin S1548 Selleck

CAS NO.

461432-26-8

Molecular Formula

 C21H25ClO6

Molecular Weight

 408.8726

Grade Standard

Medicine grade  / 99% min / GMP application / PMDA / DMF

Package Size

25kg/drum

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Dapagliflozin:

Dapagliflozin works through a non-insulin-dependent mechanism to reduce blood sugar by reducing glucose in the kidneys and directly from the urine. At the same time, weight loss and blood pressure drop are found at the secondary endpoint of the dapagliflozin study. Indications: Based on diet and exercise, this product can be used as a monotherapy for adult patients with type 2 diabetes to improve glycemic control. This product is not suitable for the treatment of type 1 diabetes or diabetic ketoacidosis.

COA of Dapagliflozin:

ITEMS

STANDARDS

RESULTS

Appearance

White powder

Complies

Identification

HPLC/NMR

Complies

Purity

Not less than 99.5%

99.85%

Assay

98.0-102.0%

99.2%

Individual impurity

Not more than 0.1%

0.04%

Total impurity

≤0.5%

0.15

Particle size distribution

D90<75μm

Complies

Residue on ignition

≤0.1%

Complies

Heavy metals

≤20ppm

Complies

Melting point

71-78℃

73.2-74.5℃

Isomer

≤0.15%

N/A

Percentage of Propanediol

13.6%~16.6%

14.3%

Water

3.0%-4.4%

3.8%

Loss on drying

≤1.0%

Complies

Optical rotation

+13° to +17°

Complies


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MORE_DETAIL Dapagliflozin 461432-26-8

Basic information of Dapagliflozin:

Name

Dapagliflozin

Alias

Bms 512148; BMS5121458; DAPAGLIFLOZIN;B MS-512148-05; Dag coluMn net; Dapagliflozin, >=98%; Dapagliflozin(BMS-512148); Dapagliflozin propanediol; Dapagliflozin Isomer Impurity; Dapagliflozin S1548 Selleck

CAS NO.

461432-26-8

Molecular Formula

 C21H25ClO6

Molecular Weight

 408.8726

Grade Standard

Medicine grade  / 99% min / GMP application / PMDA / DMF

Package Size

25kg/drum

Storage:

Keep in a well-closed container, protected from light and stored at a temperature of 2 to 8


Use of Dapagliflozin:

Dapagliflozin works through a non-insulin-dependent mechanism to reduce blood sugar by reducing glucose in the kidneys and directly from the urine. At the same time, weight loss and blood pressure drop are found at the secondary endpoint of the dapagliflozin study. Indications: Based on diet and exercise, this product can be used as a monotherapy for adult patients with type 2 diabetes to improve glycemic control. This product is not suitable for the treatment of type 1 diabetes or diabetic ketoacidosis.

COA of Dapagliflozin:

ITEMS

STANDARDS

RESULTS

Appearance

White powder

Complies

Identification

HPLC/NMR

Complies

Purity

Not less than 99.5%

99.85%

Assay

98.0-102.0%

99.2%

Individual impurity

Not more than 0.1%

0.04%

Total impurity

≤0.5%

0.15

Particle size distribution

D90<75μm

Complies

Residue on ignition

≤0.1%

Complies

Heavy metals

≤20ppm

Complies

Melting point

71-78℃

73.2-74.5℃

Isomer

≤0.15%

N/A

Percentage of Propanediol

13.6%~16.6%

14.3%

Water

3.0%-4.4%

3.8%

Loss on drying

≤1.0%

Complies

Optical rotation

+13° to +17°

Complies

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