Revised USP Chapter <467> and its Application to Excipient Qualification and Testing

GC TN-2028 Understanding the Revisions to USP Monograph <467>: Residual Solvents Sky Countryman Product Manager, Gas Chromatography Products Phenomenex Inc., Torrance, CA, USA Introduction In 1988, the United States Pharmacopoeia (USP) provided control limits and testing criteria for seven organic…

TN-2074 APPLICATIONS Residual Solvents per USP 467 using Zebron™ ZB-624PLUS and ZB-WAXPLUS GC Columns ™ ™ Ryan Splitstone, Zeshan Aqeel, and Ramkumar Dhandapani Phenomenex, Inc., 411 Madrid Ave., Torrance, CA 90501 USA Overview Residual solvents in pharmaceutical products are defined…

White Paper USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: The Agilent ICP-OES Solution Elemental Impurity Analysis Requirements Worldwide, regulatory authorities are responsible for ensuring that pharmaceutical products are both effective and safe. To achieve this, potentially harmful contaminants—including elemental…

Proposed new ICH and USP methods for elemental impurities: The application of ICP-MS and ICP-OES for pharmaceutical analysis White paper Authors Amir Liba, Ed McCurdy and Ross Ashdown Agilent Technologies Abstract The United States Pharmacopeial Convention (USP), in parallel with…