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.
Interested in learning more? Complete the form on this page to receive a free copy of the Particle Counting in Injectable Solutions application note.
Looking for a particle counter to meet USP 788 requirements? See the APSS 2000 liquid particle counter.
For more regulatory training, see the webinar, Complying with USP 729 / 788-1788 Regulatory Requirements.