BRIEFING
Esomeprazole Magnesium for Delayed-Release Oral Suspension. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in Identification A was validated using the CHIRALPAK AGP brand of column with L41 packing. The typical retention times for omeprazole R-enantiomer and esomeprazole (omeprazole S-enantiomer) are about 2 and 3 min, respectively.
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The liquid chromatographic procedure in the Assay was validated using the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for omeprazole/esomeprazole is about 4 min.
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The liquid chromatographic procedure in the test for Dissolution was validated using the Zorbax Eclipse XDB C18 brand of column with L1 packing. The typical retention time for omeprazole/esomeprazole is about 4 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Microspher C18 brand of column with L1 packing. The typical retention time for omeprazole/esomeprazole is about 18 min.
(SM3: M. Jonnada)
Case ID—SUB-2704, SUB-3237