Quality-Control Analytical Methods: Chemical Testing Aspects of USP chapter 797 for Compounded Sterile Preparations.

The regulations set forth by the United States Pharmacopeia (USP) Chapter <797>, in effect since January 1 of 2004, have generated a great deal of interest because they have established the first practice standards of sterile pharmacy compounding in US history that are enforceable at both the federal and state levels. United States Pharmacopeia Chapter <797> expands the scope of facilities governed by the regulations and defines the practices covered. The purpose of this article is to help the reader understand the criteria set forth by USP Chapter <797> regarding chemical aspects of finished-product (or end-preparation) testing, including criteria for identity and strength (potency) and beyond-use date (BUD) testing.