Challenges with Verification of Compendial Chromatographic Methods

Register free: https://www.pharmtech.com/pt_w/compendial

Event Overview:

Compendial verification is a regulatory requirement in various phases of drug development. The technical merits of a robust review of the written method and the value of demonstrating fit for purpose in your laboratory is often overlooked.

This webcast will discuss a series of case studies that illustrate the importance of performing robust compendial verification in your laboratory. Experts will describe the technical challenges encountered, while evaluating a variety of active pharmaceutical ingredients and excipients and explaining 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.
• Assess why compendial verification data is needed to ensure potential technical and safety issues are identified.
• Identify analytical details and techniques that may not be included in the compendial procedure but are essential for a robust method.

Time and Date: Thursday, May 27, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

Register free: https://www.pharmtech.com/pt_w/compendial