Analytical Strategies for USP Residual Solvents Analysis Using Agilent Gas Chromatography Coupled with Flame Ionization and Mass Spectrometry Detectors

Organic solvents are widely used in the manufacturing of active pharmaceutical ingredients (APIs). Many of these solvents are harmful and can be present in the final product as residual solvents from the manufacturing process. API manufacturers are required to monitor and control the levels of residual solvents among other impurities. The United States Pharmacopeia (USP) Method <467> is the method used worldwide for quality control, and closely follows ICH Q3C guidelines. Similar compound lists and guidelines can be found in the Pharmacopoeia of China.

In this presentation, we will present the relevant GC/FID and GC/FID/MS based analytical strategies to confidently detect and quantify Class 1, 2, and 3 as well as unknown solvents in drug products. Learn how taking advantage of dual channel configuration and Agilent’s Smart, Connected, and Self-Aware systems can help you successfully meet your requirements for residual solvent analysis and ensure your testing is right first time and every time.

Presenter: Ian Eisele (Applications Chemist, Gas Phase Separation Division, Agilent Technologies)

Presenter: Youjuan Zhang (Applications Chemist, Gas Phase Separation Division, Agilent Technologies)

Presenter: Ann Thayer (Contributing Editor, C&EN Media Group)