A Guide to Updating HPLC Compendial Methods in Pharmaceutical Analysis

Separation Science, in collaboration with Agilent, offers an on-demand webinar that discusses how changes to compendial method, known as adjustments, are made for HPLC separations and how these adjustments can be made with or without validation.

Duration: Approximately 60 minutes

Presenter

William J. Long 
(Agilent, Wilmington, Delaware, USA) 
Bill received his B.S. degree from the University of Delaware. He joined Agilent in 2001 where he currently works as an Application Scientist in the LC Columns Marketing Group. His current work includes automated method development using small particle columns for pharmaceutical and chemical analysis, and applications development using Poroshell 120 columns for chiral and other pharmaceutical analysis. He is a member of the American Chemical Society and the Delaware Valley Chromatography Forum.

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Drug producers refer to the United States Pharmacopeia-National Formulary (USP-NF), as well as European, Japanese, and British Pharmacopeias, for information on how to analyze drug substance, drug product, and associated excipients using various analytical techniques including high performance liquid chromatography (HPLC).

Manufacturers of generic drugs must be able to prove that the compounds they produce are comparable to originator-brand name drugs. In addition, they must maintain or lower the cost of the drugs production and so these methods become an important part of their processes.

One of the ways to decrease costs is to 'adjust' compendial methods, which in many cases are written with 5-micron columns. In some cases, paths to method adjustment are clear and easy. In other cases, a bit more work needs to be done.

What does it cover?

This webinar discusses how changes to compendial method, known as adjustments, are made for HPLC separations. Topics covered will include:

• Adjustments that can be made without validation
• Adjustments that require validation
• Basic (ICH) validation guidelines.

Methods presented are geometrically scaled as column volumes are adjusted, preserving chromatographic integrity per the guidelines found in USP General Chapter 621. These concepts will be demonstrated by transferring existing USP methods to smaller particle totally porous particle (TPP) or superficially porous particle (SPP) columns from their prescribed totally porous columns.

By viewing this webinar you will learn:

• How to make adjustments to compendial methods
• How to know when an adjustment will require validation
• Guidelines for (ICH) validation.

 Why should you view the presentation?

Attendees will be equipped with an understanding of the vital role of compendial methods in pharmaceutical analysis, and how by making adjustments to them they can increase laboratory efficiency and decrease costs.

To register for this on-demand webinar simply complete the form on the right. By clicking the 'View on-demand presentation' button, you submit your information to the webinar organizer, who as an independent content provider to analytical and laboratory scientists, will use it to communicate with you regarding this event and other similar platforms run in collaboration with other parties.