USP 467, Residual Solvents Becomes Official

Rockville, MD (July 1)-After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 “Residual Solvents” is now official. Closely resembling the International Conference on Harmonization’s Q3C Guideline, the chapter applies to all compendial drug substances and products and provides concentration limits of Class 1, 2, and 3 residual solvents. These items are now required to meet the requirements in this chapter, regardless of whether they are labeled “USP” or “NF.”

Unlike ICH Q3C, which only applies to new products, USP <467> applies the same requirements to all existing products. In addition, the chapter includes a section on analytical-testing methods. These methods are mainly based on headspace gas chromatography (GC) flame-ionization detection, which has been shown to be more efficient than previous techniques that relied on direct-injection GC.