Short Course Listings
Short Course

Course Information
Course Title: Implementation of United States Pharmacopeia (USP) New Chapters <232> <233> and <2232> on Elemental Impurities in Pharmaceutical Products and Dietary Supplements
Categories: 1 - Atomic Spectrometry-Spectroscopy
2 - Mass Spectrometry
3 - Pharmaceutical Sciences
4 - Quality/Regulatory/Compliance
5 - Spectroscopy
6 - Inductively Coupled Plasma
Instructor(s): Robert Thomas Course Number: 74
Affiliation: Scientific Solutions
Course Date: 03/08/2016 - Tuesday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $300 ($400 after 2/12/16) Textbook Fee: $86

Course Description
The course will provide a basic understanding and practical perspectives of the recently approved plasma-based analytical methodology described in USP Chapters <232> and <233> on elemental impurities in pharmaceutical products and Chapter <2232> on elemental contaminants in dietary supplements.

Target Audience
Targeted at personnel in the pharma/nutra industries responsible for the implementation of the new plasma-based USP methods. Attendees should preferably have used AA, ICP-OES, but also have a basic knowledge of ICP-MS. The course will also be useful for supervisors who want to understand which techniques are most suitable to carry out these analyses.

Course Outline
The Short Course will explain in greater detail all three USP Chapters, including Chapter<232> on Elemental Impurity Limits, Chapter >233> on Elemental Impurity Analytical Procedures in pharmaceutical materials and Chapter <2232> on elemental contaminants in dietary supplements. It will also give an overview of why these new methods were considered necessary. Explanation of the USP methodology will be supported by the analysis of some common pharmaceutical drugs and neutraceutical products by both ICP-MS and ICP-OES. These typical analyses will discuss which technique is most appropriate and describe sample preparation techniques, calibration procedures and how best to meet the strict quality control protocol that is an essential component of analyzing samples according to the new USP methodology.

Course Instructor's Biography
: Robert Thomas has worked in trace element analysis for over 40 years…8 years as an analytical chemist in the metallurgical industry….22 years in application support, product development and marketing for a manufacturer of ICP-MS instrumentation …. and 13 years as principal of his own consulting company. He has served on the ACS Reagent Chemical Committee for the past 13 years where he has worked closely with the United States Pharmacopeia to align the testing procedures for elemental impurities in reagent chemicals with those of pharmaceutical and neutraceutical materials. He has authored over 80 publications on trace element analysis and written three textbooks on the real-world applications of ICP-MS. His most recent book entitled “Practical Guide to ICP-MS: a Tutorial for Beginners” includes a chapter dedicated to the analysis of pharmaceutical products. He has an advanced degree in analytical chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC).