News

Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

USP 467, Residual Solvents Becomes Official

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.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More