System Suitability Requirements and Update on Harmonization of USP General Chapter <621> Chromatography

This webinar will cover the system suitability requirements and recommended adjustments to specific chromatographic systems in the USP monographs based on General Chapter <621> Chromatography. We will also discuss the most recent updates on proposed harmonization of this general chapter with EP and JP and how to implement the procedures after the change is effective.

Why Should You Attend:

<621> is one of the most important USP general chapters impacting about 5000 USP monographs. Establishing meaningful system suitability criteria for chromatography procedures are requirements for a valid procedure and compendial and regulatory compliance.

In this webinar Dr. Davani will discuss an overview of system suitability requirements, and allowed adjustments to specific chromatographic systems in the USP monographs based on General Chapter <621> Chromatography. In addition, the update on harmonization of this general chapter with the two other major pharmacopeias (EP and JP) will be discussed for the smooth procedure implementation by users when these changes become official.

Use of alternative method to compendial (official) procedure and the potential options available will be discussed. In addition, guidance on identifying effective system suitability parameters and acceptance criteria for up-to-date (modernized) USP monographs as well as different quantitation strategies for impurities will be provided.