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
Using Core-Shell Technology to Improve HPLC Methods within USP: Part 1
Harnessing the Power of Core-Shell Technology to Improve Older, Validated HPLC Methods Within Acceptable USP Guidelines Part One: Quality Control Methods Guest Author: Dr. Jeff Layne Hello everyone, I hope 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
What is USP Chapter 621?
The United States Pharmacopeia (USP) has defined the limits of “allowable adjustments” in USP General Chapter <621>, where revalidation is required if adjustment limits are exceeded. Even though this chapter Continue Reading