Assessment of residual solvents in pharmaceuticals to updated ICH Q3C R8 and USP 467

by | Impurity Analysis, Pharmaceutical

ASTS_Campaign_Image_265The manufacturing process for active pharmaceutical ingredients (APIs) may contribute to residual solvents remaining in the final product. These organic solvents are widely used in the synthesis of pharmaceutical products and cannot always be completely removed during the manufacturing processes. API manufacturers are required to monitor and control the levels of residual solvents among other impurities.

United States Pharmacopeia (USP) Method is the method used worldwide for quality control, and closely follows ICH Q3C guidelines. Updates to the ICH Q3C guideline expand the testing required for formulations.

Agilent has organized an online event, the '2021 Agilent Science and Technology Virtual Symposium (ASTvS 2021)', which will take place globally on 5 May. If this date is not convenient, the entire symposium will also be available o=in on-demand format through to 19 May. As part of this educational event you can listen to Ian Eisele give a presentation titled 'Assessment of residual solvents in pharmaceuticals to updated ICH Q3C R8 and USP 467', where you will learn how Agilent's Residual Solvents Analyzer; built to meet the USP 467 requirement is the ideal solution to your testing needs with the Smart, Connected and Self Aware capabilities of Agilent's latest systems ensuring your testing is right first time and every time.

Ian Eisele is currently part of the marketing applications team with Agilent in Wilmington, Delaware. Working on new workflows, applications and commercialization of new solutions and instruments, Ian's customer focus from many years as a customer engineer gives a valuable insight to user's needs. Ian has been with Agilent for over a decade and is currently working with the latest smart GC systems and the introduction of the 8697 Headspace Sampler.

Other presentations at ASTvS include:

Innovation at Agilent - accelerating next generation science
Speaker: Darlene J S Solomon, Ph.D., Chief Technology Officer and Senior Vice President, Agilent Technologies, USA

Vitamin and Amino Acid analysis for nutritional labelling
Speaker: Ansuman Mahato, LC Application Specialist, Agilent Technologies, India

OpenLab - Benefits of Virtualization and Cloud Environments
Speaker: William Goodman, Director of Product Management for Software & Informatics, Agilent Technologies, USA

Enabling science. Simplifying services with CrossLab Lab-Wide Services
Speakers: Brian Duffy, Service Business Consultant, Agilent Technologies, USA and
Brittany Stille, Product Manager of Lab-Wide Instrument Services, Agilent Technologies, USA

OpenLab - An Integrated Informatics systems for greater efficiency and data integrity
Speaker: Thomas Schmidt, Marketing Director for Software & Informatics, Agilent Technologies, Germany

Published  May 1, 2021

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