Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)

USP general chapter <857> and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification as per global pharmacopoeias’ requirements.

UV-Vis spectroscopy is a widely used analytical technique in quality assurance/ quality control (QA/QC) and pharmaceutical research. It is critical that any laboratory in such environments set up appropriate controls for laboratory access and ensure that good manufacturing practice (GMP) documentation, including system suitability tests (SSTs) and standard operating procedures (SOPs) are available and followed. The United States pharmacopoeia (USP) and the European pharmacopoeia (Ph. Eur.) guidelines describe how to verify that the analytical performance of UV-Vis spectrophotometers is suitable for the intended operational range of the analysis.