This month's "Validation Viewpoint" column examines the reasons behind problems with new drug applications submitted to the U.S. Food and Drug Administration (FDA). Ira Krull and Michael Swartz look at specific problems within analytical methods that raise red flags at the FDA.
Given the increasing number of chiral samples and the time constraints under which chromatographers work, choosing an appropriate chiral stationary phase for the resolution of enantiomers can be challenging. In this article, the authors describe a screening approach for chiral HPLC method development.
In this month's "GC Connections," John Hinshaw examines optimization strategies for gas chromatography columns in the second installment of a multipart series. He starts with a question from a reader and then discusses broader column issues.
This month's "Column Watch" examines developments in column packings. Ron Majors looks at the physical design of packing materials from a performance standpoint and discusses some new packing materials that have unique characteristics.