Monitoring Particles in Injectables for USP 788 and EP6
Testing of finished injectable solutions requires compliance to both the USP 788 and, where European regulation need to be met, EP6. See below to learn about requirements from the papers and find solutions from the products shown.
For further information on USP 788, or for specific pharmaceutical monitoring questions, please contact Mark Hallworth, Pharmaceutical Specialist, at 303.443.7100 or mhallworth@pmeasuring.com
Papers
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Particle Counters for Injectable Solutions, 2007 USP Update (244.3 KB) Learn about the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards, including the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that... Download above file for full tables and figures, or for overview, see HTML Version. |
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Basic Guide to Particle Counters and Particle Monitoring (441.3 KB) This overview of particle contamination starts by discussing sources of contamination and monitoring technologies available, and continues by discussing various... Download above file for full tables and figures, or for overview, see HTML Version. |
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