USP 467, Residual Solvents Becomes Official

July 3, 2008
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now 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.

To help companies comply with the new requirements, USP is offering web-based courses from July 17 to July 29.