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 prove that the generic compounds they produce are comparable to originator-brand name drugs. In addition, these generic drugs need to be manufactured in a way to maintain or lower the cost of the drugs production. As a result, these modified 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 by using 5-micron columns to develop the original method. With the latest development in column technology, columns with smaller particle size, providing shorter run times have been manufactured. These columns can be used to modernize the existing compendial methods. In some cases, paths to method adjustment are clear and easy. In other cases, a bit more work needs to be done.
In this webinar the presenter will discuss strategies for:
- Adjustments that can be made without validation including new GRADIENT changes
- Adjustments that require validation
- Basic (ICH) validation guidelines
Key learning objectives:
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.
Who should attend:
Individuals interested in acquiring knowledge about the enhancement of HPLC compendial methods in pharmaceutical analysis or those seeking to leverage the most recent advancements in HPLC column technology to expedite their methods and reduce solvent costs are encouraged to participate. Embracing sustainability for the future is a key focus.