Guest Author: Dr. Jeff Layne Part V: Some Final Points on the Chromatographic Impact of Making Adjustments to Existing Methods We are finally coming to the end of our series, Continue Reading
Using Core-Shell Technology To Improve HPLC Methods Within USP: Part 4
Part IV: More about the Chromatographic Impact of Making Adjustments to Existing Methods Guest Author: Jeff Layne, Ph.D. Welcome to the fourth part of the series that is examining the effects Continue Reading
Using Core-Shell Technology to Improve HPLC Methods Within USP: Part 3
Part III. Chromatographic Impact of Making Adjustments to Existing Isocratic Methods Guest Author: Jeff Layne, Ph.D. Welcome back to the third article of my series “Using Core-Shell Technology to Improve Continue Reading
SEC Method Optimization using the Ph. Eur. for Insulin Fibrils
Insulin is a peptide hormone which plays a significant role in metabolism. In its monomer form, insulin can partially misfold, causing a cascade of non-native cross assembly of beta-pleated sheets Continue Reading
Using Core-Shell Technology to Improve HPLC Methods within USP: Part 2
Harnessing the Power of Core-Shell Technology to Improve Older, Validated HPLC Methods within Acceptable European Pharmacopeia Guidelines. Guest Author: Dr. Jeff Layne Welcome back to the second article on harnessing Continue Reading
Revision of European Pharmacopeia (EP) Chapter 2.2.46
Guest Author: Dr. Heiko Behr– European Pharmaceutical Senior Business Development Manager The European Pharmacopeia (EP) Chapter 2.2.46 contains information that is similar to the USP Chapter 621. This includes general Continue Reading
Allowable Adjustments to Pharmacopoeia Methods: Simplified Version
Effective August 2014, the United States Pharmacopoeia and the National Formulary published the latest revision to General Chapter on Chromatography that further clarifies what “allowable adjustments” can be made to USP methods without having to revalidate these methods.