Everolimus Tablets for Oral Suspension

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BRIEFING

Everolimus Tablets for Oral Suspension. 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 procedures in the Assay and the Organic Impurities test were validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for everolimus is about 22 min.
The liquid chromatographic procedure in the Dissolution test was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for everolimus is about 3.5 min.

(SM1: M. Fadadu)

Case ID—SUB-753

USP REFERENCE STANDARDS FOR PURCHASE

USP Everolimus RS
USP Everolimus System Suitability Mixture RS

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