BRIEFING
Zolpidem Tartrate Sublingual Tablets. 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 Nova-Pak C18 brand of column with L1 packing. The typical retention time for zolpidem is about 6 min.
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The liquid chromatographic procedure in the Dissolution test was validated using the XTerra MS C18 brand of column with L1 packing. The typical retention time for zolpidem is about 4 min.
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The liquid chromatographic procedure in the test for Organic Impurities was validated using the XTerra MS C18 brand of column with L1 packing. The typical retention time for zolpidem is about 12 min.
(SM4: R. Nguyen)
Correspondence Number—C188690