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Esomeprazole Magnesium 217087-09-7 Esomeprazole Magnesium 217087-09-7

Esomeprazole Magnesium 217087-09-7
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Basic information of Esomeprazole magnesium trihydrate

Name

Esomeprazole magnesium trihydrate

Alias

bis(5-methoxy-2-[(s)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1h-benzylimidazole-1-yl) magnesium trihydrate;
(T-4)-Bis[5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazolato]magnesium;
Nexium;
ESOPMEPRAZOLE MG TRIHYDRATE;
5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide;
5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

CAS NO.

217087-09-7

Molecular Formula

C34H42MgN6O9S2

Molecular Weight

767.17

Brief Introduction

Esomeprazole is the S-isomer of omeprazole, which reduces gastric acid secretion by a specific targeting mechanism and is a specific inhibitor of proton pumps in parietal cells. The R- and S-isomers of omeprazole have similar pharmacodynamic properties.


Use of Esomeprazole magnesium trihydrate:

Esomeprazole Magnesium for the Treatment of Gastroesophageal Reflux Disease (GERD) - Treatment of Erosive Reflux Esophagitis - Long-Term Maintenance Therapy for Relapse Prevention for Esophagitis Patients Who Have Been Cured - Gastroesophageal Reflux Disease (GERD) Symptoms of the Controlled Combine with the Proper Antimicrobial Therapy Combination to Eradicate the Helicobacter Pylori and - Healing of Duodenal Ulcers Associated with Helicobacter Pylori Infection - Preventing Recurrence of Helicobacter Pylori-Related Peptic Ulcers.

COA of Esomeprazole magnesium trihydrate :

 TEST ITEM  Characters  STANDARDS REOUIRED  TEST RESULTS
 Characters  White or slightly coloured powder,slight hygroscopic Almost white powder
ldetineation
A. IR  IR Conforms to the CSR (2.2.24) Complies
B. Enantionmeric purity Impurity F≤0.2%(2.2.29) 0.05%
C. Reaction of magnesium It gaves reaction of magnesium(2.3.1) Complies
D. Water 6.2%-8.0%(2.5.12) 7.30%
Test
Absorbance The absorbance is not greater than 0.20 at 440nm. 0.12
(2.2.25)
Related substances(HPLC) (2.2.29)
Impurity E ≤0.15% 0.04%
Impurity D ≤0.15% 0.10%
Unspecified impurities ≤0.10% 0.03%
Total impurity ≤0.30% 0.20%
Impurity F ≤0.20%(2.2.29) 0.05%
Magnesium 3.30%-3.55% 3.46%
Water by K.F 6.2%-8.0%(2.5.12) 7.30%
Assay(HPLC) 98.0%-102.0%(2.2.29) 99.90%
Residual sovents:
a) Acetone Not more than 5000ppm 3ppm
b) Ethyl acetate Not more than 5000ppm Not detected
c) Methylene chloride Not more than 100ppm Not detected
d) Methanol Not more than 3000ppm 77ppm
e) Toluene Not more than 890ppm Not detected
f) Benzene Not more than 2ppm Not detected
Results: The commodity meets the standard of EP8.2


MORE_DETAIL Esomeprazole Magnesium 217087-09-7

Basic information of Esomeprazole magnesium trihydrate

Name

Esomeprazole magnesium trihydrate

Alias

bis(5-methoxy-2-[(s)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1h-benzylimidazole-1-yl) magnesium trihydrate;
(T-4)-Bis[5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazolato]magnesium;
Nexium;
ESOPMEPRAZOLE MG TRIHYDRATE;
5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide;
5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

CAS NO.

217087-09-7

Molecular Formula

C34H42MgN6O9S2

Molecular Weight

767.17

Brief Introduction

Esomeprazole is the S-isomer of omeprazole, which reduces gastric acid secretion by a specific targeting mechanism and is a specific inhibitor of proton pumps in parietal cells. The R- and S-isomers of omeprazole have similar pharmacodynamic properties.


Use of Esomeprazole magnesium trihydrate:

Esomeprazole Magnesium for the Treatment of Gastroesophageal Reflux Disease (GERD) - Treatment of Erosive Reflux Esophagitis - Long-Term Maintenance Therapy for Relapse Prevention for Esophagitis Patients Who Have Been Cured - Gastroesophageal Reflux Disease (GERD) Symptoms of the Controlled Combine with the Proper Antimicrobial Therapy Combination to Eradicate the Helicobacter Pylori and - Healing of Duodenal Ulcers Associated with Helicobacter Pylori Infection - Preventing Recurrence of Helicobacter Pylori-Related Peptic Ulcers.

COA of Esomeprazole magnesium trihydrate :

 TEST ITEM  Characters  STANDARDS REOUIRED  TEST RESULTS
 Characters  White or slightly coloured powder,slight hygroscopic Almost white powder
ldetineation
A. IR  IR Conforms to the CSR (2.2.24) Complies
B. Enantionmeric purity Impurity F≤0.2%(2.2.29) 0.05%
C. Reaction of magnesium It gaves reaction of magnesium(2.3.1) Complies
D. Water 6.2%-8.0%(2.5.12) 7.30%
Test
Absorbance The absorbance is not greater than 0.20 at 440nm. 0.12
(2.2.25)
Related substances(HPLC) (2.2.29)
Impurity E ≤0.15% 0.04%
Impurity D ≤0.15% 0.10%
Unspecified impurities ≤0.10% 0.03%
Total impurity ≤0.30% 0.20%
Impurity F ≤0.20%(2.2.29) 0.05%
Magnesium 3.30%-3.55% 3.46%
Water by K.F 6.2%-8.0%(2.5.12) 7.30%
Assay(HPLC) 98.0%-102.0%(2.2.29) 99.90%
Residual sovents:
a) Acetone Not more than 5000ppm 3ppm
b) Ethyl acetate Not more than 5000ppm Not detected
c) Methylene chloride Not more than 100ppm Not detected
d) Methanol Not more than 3000ppm 77ppm
e) Toluene Not more than 890ppm Not detected
f) Benzene Not more than 2ppm Not detected
Results: The commodity meets the standard of EP8.2

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