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 |
IdentificationA. IRB.Enantiomeric purityC.Reaction of maganesiumD. 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) |
Complies0.05%Complies7.3% |
Absorbance |
The absorbance is not greater than 0.20 at 440nm.(2.2.25) |
0.12 |
Related substances(HPLC)Impurity EImpurity DUnspecified impuritiesTotal impurityImpurity 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) Acetoneb)Ethyl acetatec)Methylene chlorided)Methanole)Toluenef)Benzene |
Not more than 5000ppmNot more than 5000ppmNot more than 100ppmNot more than 3000ppmNot more than 890ppmNot more than 2ppm |
3ppmNot detectedNot detected77ppmNot detectedNot detected |
Usage |
(All Rights Reserved) (All Rights Reserved)
