Analytical UV/VIS absorption spectrophotometers are laboratory workhorses in the FDA-regulated healthcare industry. They play critical roles in analytical testing, quality control and manufacturing support. Being inclusive in regulatory requirements for analytical instrument qualification (AIQ), spectrophotometer performance is of vital importance and is an area of focus in many laboratory types of regulatory audits and quality assurance inspections. The scientific treastise highlights include, but are not limited to, the following:

  1. Analytical Instrument Qualification – Absorption Spectrophotometers Operating in Ultraviolet (UV) and Visible (VIS) Spectral Regions
    •  USP – Attributes and Shortcomings
    • Instrumental Test Parameters
      • Resolution
      • Stray Radiant Energy (Stray Light)
      • Wavelength Scale Accuracy
      • Photometric Scale Properties
        • Photometric Accuracy
        • Photodetector Linearity
      • Sample Cell Pathlength