Challenges with Verification of Compendial Chromatographic Methods

Overview:

This webcast will discuss a series of case studies that illustrate the technical merits for performing robust compendial verification in your laboratory. Our experts will talk through the technical challenges encountered, while evaluating a variety of active pharmaceutical ingredients and excipients and how those challenges were resolved.

Challenges include:

• Sample preparation methodology that led to ruptured vials
• High purity reference standards unavailable from commercial sources
• Reference standards of uncertain purity or potentially contaminated
• Standard preparation methods that may be hazardous or present safety concern

Key Learning Objectives:

• Understand the value added by performing compendial verification to demonstrate suitability under the actual conditions of use in your laboratory.
• Assessment of compendial verification data is needed to ensure potential technical and safety issues are identified.
• Compendial verification identifies analytical details and techniques that may not be included in the compendial procedure but are essential for a robust method.

Who Should Attend:

• QC chemists
• R&D chemists
• QC laboratory management
• Quality Assurance personnel

Event Teaser: Compendial verification is a regulatory requirement. Often overlooked are the technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory. Our experts will share experiences gained over years of evaluating hundreds of methods to help you avoid similar obstacles and delays in your laboratory.

James Joslin, BS
Raw Material Chromatography Area Supervisor

Adam Ketola, BS
Senior Scientist