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

The 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.

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