Mass Spectrometry & Spectroscopy

  • CertiRef<sup>TM</sup> - Automated and Pharmacopoeia-Compliant Performance Verification

CertiRefTM - Automated and Pharmacopoeia-Compliant Performance Verification

Mar 13 2020 Read 2557 Times

Spectrophotometer performance is the main factor directly affecting the accuracy and repeatability of measurements. It is therefore important that it be routinely monitored in regulated environments, and that documentary evidence is provided. As the procedure for performance verification is intricate and time-consuming, there are substantial benefits to integrating it into the analytical workflow. For this reason, METTLER TOLEDO has developed an accessory, CertiRef™, for automatic calibration and performance tests of the UV/VIS Excellence spectrophotometer instrument line. The CertiRef™ module offers a full, pharmacopoeia-compliant solution for automated performance verification of the UV/VIS Excellence spectrophotometers UV7, UV5 and UV5Bio, with simple plug-and-play operation and traceable results that meet data integrity requirements.

The USP and Ph.Eur describes widely accepted guidelines for spectrophotometer performance verification to ensure that results are representative and correct. Tests recommended include checks of photometric accuracy and repeatability, wavelength accuracy and repeatability, instrument resolution and stray light measurement. The US and European pharmacopoeia chapters on UV/VIS spectroscopy have recently been revised to additionally include the verification of photometric linearity. To keep abreast of the changes - mandatory from the end of 2019 - METTLER TOLEDO offers CertiRef™ automated performance verification accessories so that the compliance of all customers is maintained.

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