Itraconazole Oral Solution

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BRIEFING

Itraconazole Oral Solution. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

The liquid chromatographic procedure in the Assay was validated using the Xterra RP18 brand of column with L1 packing. The typical retention time for itraconazole is about 23 min.
The liquid chromatographic procedure in the Organic Impurities test was validated using the Gemini C18 brand of column with L1 packing. The typical retention time for itraconazole is about 33 min.

(SM1: M. Fadadu)

Case ID—SUB-191

USP REFERENCE STANDARDS FOR PURCHASE

USP Itraconazole RS
USP Itraconazole System Suitability Mixture RS

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