Is your spectrophotometer still "Pharma compliant"? A review of the new European Pharmacopoeia 10th Edition

Hulme and Hammond focus on the new European Pharmacopoeia 10th Edition. European Pharmacopoeia (EP) Chapter 2.2.25 on ultraviolet and visible spectroscopy (or spectrophotometry) has been extensively revised in both detail and scope and the new Edition 10.01 (10.0) is mandatory from 1 January 2020. A major change is that the scope is now extended to include high-performance liquid chromatography (HPLC) detectors and process analytical technology (PAT) as applications of ultraviolet/visible (UV/vis) spectrophotometry. The authors explore the new regulations only in so far as they apply to basic spectrophotometry. The new Edition introduces some new approaches to instrument qualification and suggests new reference materials for qualification measurements.