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注射溶液的粒子計數 2007 更新

Abstract

Particle Counting in Injectable Solutions 2007 Updates

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:

  1. USP recently updated in April 2007 and undertakes a new course on testing.
  2. EP changed to include SVI products in 2005.
  3. JP updated to JP in 2006.

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