Function: | Digestive System Agents |
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Certification: | GMP |
Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Samples: |
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Items | Standard |
Appearance
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White or slightly coloured powder,slightly hygroscopic
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Solubility
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slightly soluble in water,soluble in methanol,practically insoluble in heptane.
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Identification
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The spectra obtained should be in accordance with that of esomeprazole magnesium trihydrate CRS(IR)
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It should give the reaction of magnesium
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Absorbance
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Not more than 0.20(440nm)
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Magnesium content
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Calculation on anhydrous substance basis,3.3%to3.55%
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Water determination
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6.0%~8.0%
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R-omeprazole
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Not more than 0.2%
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Related substances
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Omeprazole impurity A:Not more than0.10%
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Any other individual related substance:Not more than
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Total impurities:Not more than
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Residual solvents
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Methylene chloride:Not more than 600ppm
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Methylbenzene:Not more than 890ppm | |
Methanol:Not more than 3000ppm | |
Ethyl acelate:Not more than 5000 ppm | |
Assay(on the anhydrous basis) | 98.0%-102.0% |
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