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Esomeprazole Magnesium Trihydrate 217087-09-7

Esomeprazole Magnesium Trihydrate 217087-09-7

EP9, CEP
  • Product Details

Product Information


Product name

Esomeprazole Magnesium Trihydrate

Synonyms

Bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzylimidazole-1-yl) magnesium trihydrate

CAS No.

217087-09-7

Molecular Formula

2(C17H18N3O3S).Mg.3(H2O)

Molecular Weight

767.17

Quality Standard

98% up, Medicine Grade

Appearance

White powder


COA of Esomeprazole Magnesium Trihydrate


Test items

Specifications

Result

Appearance

White or slightly coloured powder,slight hygroscopic

almost white powder

Identification

A. IR

B.Enantiomeric purity

C.Reaction of maganesium

D. Water

 

IR Conforms to the CRS.(2.2.24)

Impurity F  ≤0.2%(2.2.29)

It gives reaction of magnesium(2.3.1)

6.2%~8.0%(2.5.12)

 

Complies

0.05%

Complies

7.3%

Absorbance

The absorbance is not greater than 0.20 at 440nm.(2.2.25)

0.12

Related substances(HPLC)

Impurity E

Impurity D

Unspecified  impurities

Total impurity

 Impurity F 

(2.2.29)

≤0.15%

≤0.15%

≤0.10%

≤0.3%

≤0.2%(2.2.29)

 

0.04%

0.10%

0.03%

0.2%

0.05%

Magnesium

3.30%~3.55%

3.46%

Water by K.F.

6.2%~8.0%(2.5.12)

7.3%

Assay(HPLC)

98.0%~102.0%(2.2.29)

99.9%

Residual solvents:

a) Acetone

b)Ethyl acetate

c)Methylene chloride

d)Methanol

e)Toluene

f)Benzene

 

Not more than 5000ppm

Not more than 5000ppm

Not more than 100ppm

Not more than 3000ppm

Not more than 890ppm

Not more than 2ppm

 

 

 

3ppm

Not detected

Not detected

77ppm

Not detected

Not detected


Usage


Function of Esomeprazole Magnesium Trihydrate

Esomeprazole Magnesium Trihydrate is used as drugs for gastroesophageal reflux gastropathy and antacids and anti-ulcer.


1. Gastroesophageal reflux disease (GERD).

2. Treatment of erosive reflux esophagitis.

3. Long-term maintenance treatment for patients with cured esophagitis to prevent recurrence.

4. Symptom control of gastroesophageal reflux disease (GERD) combined with appropriate antibacterial therapy to eradicate Helicobacter pylori.

5. Heals duodenal ulcers associated with Helicobacter pylori infection.

6. Prevent the recurrence of peptic ulcers related to Helicobacter pylori.

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Send A Message
Send A Message
If you are interested in our products and want to know more details,please leave a message here,we will reply you as soon as we can.

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