Esomeprazole Magnesium Trihydrate

CAS number: 217087-09-7

Molecular formula: C34H42MgN6O9S2

molecular weight: 767.2

Chemical structure:

SR. NOTESTSPECIFICATIONRESULTS
1.DescriptionWhite to slightly coloured powderOff white color powder
2.SolubilitySoluble in methanol; slightly soluble in water, practically insoluble in heptane.Complies
3.Identification

a)     By IRIR spectrum of test sample should concordant wit IR spectrum of working
standard.
Complies
b)    By AASThe sample solution, prepared and tested as directed in the test for content of Magnesium, exhibits a significant
absorption at 285.2 nm.
Complies
4.Content of MagnesiumShould be between 3.30% and 3.55% (On
anhydrous basis).
Complies
5.Colour of solutionThe absorbance of the solution at 440 nm, in 1-cm cells, should not be more than 0.2 Abs.Complies
6.Water contentShould be between 6.0% w/w and 8.0%
w/w
6.9%
7.Related substances by HPLC
Omeprazole N-OxideNot more than 0.1%Not detected
Omeprazole SulfoneNot more than 0.2%Not detected
Any other individual impuritiesNot more than 0.1%0.02%
Total impuritiesNot more than 0.5%0.08%
8.Enantiomeric purityNMT 0.2 % of the R-enantiomer.0.10%
9.Asaay by HPLCNot Less than 98.0% w/w and
Not more than 102.0% w/w
99.3% W/W