Pharmacopoeia changes – what to check for on UV/Vis spectrometers, and how.
ABOUT THIS WEBINAR
Pharmacopoeias are regulatory bodies who define guidelines on the procedures and analytical instrumentation for the preparation and analytical measurement of pharmaceutical products. Both the American and European Pharmacopoeias, USP and Ph. Eur., respectively, have a dedicated chapter on the requirements of UV/Vis spectrophotometers and the verification of their performance. Pharmaceutical companies are facing the challenge of adapting their workflow to Pharmacopoeia regulation revisions that became mandatory at the beginning of 2020. Keeping on a par with the changes and supporting compliance requirements, HELLMA provides a large programme of certified reference materials. Some of them are integrated into automated performance verification accessories from METTLER TOLEDO.
This webinar provides an overview of the important UV/Vis spectroscopy-relevant changes in both USP and Ph. Eur. taking a closer look at their impact and the solutions available to ensure compliance.
The verification of photometric linearity has not been mandatory until this latest revision; this test is now explicitly defined in both USP 42-NF37 2nd supp. and Ph. Eur. 10. These parameters are assessed by performing spectroscopic measurements using different liquid or solid filters, depending on the test.
In the second section of this webinar the positive impact of automation on workflow efficiency and security in optical performance verification of UV/Vis spectrophotometers with certified liquid reference materials will be assessed against manual execution. As the procedure for comprehensive performance verification is intricate and time consuming there are great benefits in integrating it in the analytical workflow and having it automatically executed. Furthermore, the importance of automatic data integrity compliant management of certification data will be emphasised as an important parameter for regulation compliant documentation.
Learning outcomes of this webinar:
- Know the changes in the respective optical chapters of USP 42 – NF37 2nd and Ph. Eur. 10
- Know which Certified Reference Materials may be used for which parameter check
- Know the consequences on optical performance verification of UV/Vis spectrophotometers
- Benefits of automated performance verification.
Dr Hans-Joachim Muhr, Head of Strategic Product Group UV/VIS, Mettler-Toledo GmbH
Hans-Joachim Muhr has a PhD in Chemistry, Exec. MBA and16 years’ experience in project innovation management, global sales and marketing for titration automation products. He has eight years of executive management responsibility in analytical instrument businesses (UV/Vis, Thermal Values).
Thomas Brenn, Product Manager, Hellma GmbH & Co. KG
Thomas Brenn has eight years of experience in product management of certified reference materials and high precision cuvettes for UV/Vis spectroscopy.