BRIEFING
Levocetirizine Dihydrochloride Oral Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the ZORBAX SB Phenyl brand of column with L11 packing. The typical retention time for levocetirizine is about 13 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the Kinetex Biphenyl brand of column with L11 packing. The typical retention time for levocetirizine is about 72 min.
(SM5: G. Daddala)
Case ID—SUB-1930
