Sample Preparation: Revised USP Chapter for Elemental Impurities

The United States Pharmacopeia (USP) has developed a new test for elemental impurities in drug products which will be official in mid of 2013. The new general chapter <232> (Limits) and <233> (Procedures) will replace the cur-rent USP <231> (metallic impurities). The revised chapters present new procedures, e.g. closed vessel digestion, for the evaluation of analytes. The following paper intents to explain how Berghof digestion systems comply with the requirements of the new method.