Would you like to learn more about the vital role of compendial methods in pharmaceutical analysis and how, by making adjustments to them, laboratory efficiency can be increased and cost decreased? If so, this on-demand webinar will provide the answers.
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.
By viewing this presentation 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 it?To learn more about the vital role of compendial methods in pharmaceutical analysis and how, by making adjustments to them, laboratory efficiency can be increased and cost decreased.
William J. Long
(Agilent, Wilmington, Delaware, USA)
Bill received his B.S. degree from the University of Delaware. He completed his Ph.D. in Analytical Chemistry from Virginia Commonwealth University, where part of his research included analysis of derivatized amino acids. He worked at Himont/Montell Polyolefins/Basell in Wilmington, Delaware and Elkton, Maryland as a Research Scientist where he provided analytical support in HPLC, polymer fractionation, size exclusion chromatography, and regulatory extractable analysis in the development of new polymers and polymer additives. 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.