Type of Posting: Revision Bulletin: Notice of Harmonized Text
Posting Date: 04–Apr–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."
The Evaluation subsections for the Light Obscuration Particle Count Test and the Microscopic Particle Count was revised to show the correct testing criteria for preparations supplied in containers with a nominal volume of 100 mL.
We apologize for this error and provide here a corrected PDF of <788> Particulate Matter in Injections.
Questions should be directed to Dr. Desmond Hunt, Scientific Liaison, PPI Expert Committee (dgh@usp.org or 301-816-8341).