Metrolab Blog

How to Analyze Residual Solvents? ChroZen USP 467 Player

For pharmacopeial purposes, residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. Because residual solvents have notherapeutic benefits but harmful effects to human body if they remain in the final products, it is required to regulate these compounds not to exceed the specific limits defined in certain regulations.
In this study, the determination of residual solvents (Class 1 & 2) in pharmaceutical products by ChroZen GC/FID with Headspace was conducted according to the method (Procedure A) specified in USP 467.