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 Not detected 77ppm Not detected Not detected