Particle Counting in Injectable Solutions

This paper discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP <788> (USP 42 2018), EP 5.1 and JP 17 release information. These standards demand that injectable solutions are effectively monitored for microcontamination, specifically nonsoluble particulates.
Past notable changes have occurred to all of the three standards, namely:

• USP <788>, updated in April 2007, undertakes a new course of testing.
• EP changed to include SVI products in 2005.
• JP released its 17th edition in 2016.

 

Download this paper for an overview of injectable solution history and monitoring methods.