Contagem de partículas em soluções injetáveis — atualizações de 2007
This paper discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP <788> (April 2007), EP 5.1 and JP 15 release information. These standards demand that injectable solutions are effectively monitored for microcontamination, specifically non-soluble particulates.
Notable changes have occurred to all of the three standards, namely:
- USP recently updated in April 2007 and undertakes a new course on testing.
- EP changed to include SVI products in 2005.
- JP updated to JP in 2006.
Interested in learning more? Complete the form on this page to receive a free copy of the Particle Counting in Injectable Solutions 2007 Updates application note.