Interim Revision Announcement

Notice of Harmonized Text: USP–NF General Chapter <788> Particulate Matter in Injections


March 30, 2007

The harmonized text for General Chapter <788> has been approved by the Parenteral Products—Industrial Expert Committee, Dr. Steven L. Nail, Chair and will become official on April 1, 2007. The changes include verbatim harmonized text as proposed in the European and Japanese pharmacopoeias, and reflect alignment with the 2004 signed-off text of the Pharmacopoeial Discussion Group (PDG).

The harmonized chapter, which becomes official via an Interim Revision Announcement in PF 33(2), references a definition for particle-free water in Reagents, Indicators and Solutions. That definition will read "Particle-Free Water: Filter water through a membrane with a pore size of 0.22 µm."

Questions should be directed to Dr. Desmond Hunt, Scientific Liaison, PPI Expert Committee ( or 301-816-8341).