Technical / White Paper
METHOD VALIDATION – USP PROPOSED <233>
The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contaminating heavy metals in drug products. The new USP <233> describes testing methods to detect elements of interest specifically, accurately and with high sensitivity, enabling detection at levels of ppb and lower. This Technical Bulletin details method validation performed at SGS Life Science Services’ laboratory in Lincolnshire, IL (USA).