Partikelzählung in injizierbaren Lösungen, Aktualisierungen von 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.
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