EP9, CEP Esomeprazole Magnesium Trihydrate 217087-09-7

Name: EP9, CEP Esomeprazole Magnesium Trihydrate 217087-09-7
Availability: ep9-cep-esomeprazole-magnesium-trihydrat-273808.html

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:EP9, CEP Esomeprazole Magnesium Trihydrate 217087-09-7
CAS No.:217087-09-7
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

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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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EP9, CEP Esomeprazole Magnesium Trihydrate 217087-09-7

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