Explanatory Note

Erratum to <788> Particulate Matter in Injections and the USP Particle Count Reference Standard


August 1, 2007

This Erratum inserts national text into harmonized General Chapter <788> to inform users that the USP Particle Count Reference Standard can be used to determine system suitability of light obscuration equipment.

The current version of General Chapter <788> Particulate Matter in Injections (amended via direct IRA in Pharmacopeial Forum 33(2), and later updated via a Revision Bulletin posted on the USP Web site April 4, 2007) indicates the use of the USP Particle Count Reference Standard as a calibration standard, which is an incorrect usage for that standard. The USP Particle Count Reference Standard is a system suitability standard that can be used to verify the calibration of the light obscuration equipment, and is not used for calibration.

The complete text  (79KB), which also will be published as an Interim Revision Announcement in PF 33(6), is official as of this date and is included in this web posting. The text now includes the original harmonized text followed by the national text that states that the USP Particle Count Reference Standard can be used to determine system suitability.

For further information, contact Desmond Hunt, Ph.D., liaison to the Parenteral Products Industrial Expert Committee ().