Esomeprazole Magnesium Trihydrate 217087-09-7

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

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