An upcoming webinar will provide an understanding of the new standards and guidelines in Elemental Impurities for the pharmaceutical industry.

In 2005, the United States Pharmacopeia (USP) began the process of replacing the sulfide precipitation-based Heavy Metals general chapter 231 with atomic spectroscopy-based standards, Elemental Impurities chapters 232 and 233.

A decade later, these standards are set to become regulatory enforceable, with the most recently published implementation date provided by USP stated as December, 2015. These standards represent a dramatic departure from the venerable Heavy Metals test (used both by the US and in Europe), as a specific list of elements is provided.

Each element is associated with a specific permissible daily exposure limit (PDEs) for various routes of administration. More recently, the International Conference on Harmonization (ICH) has published the Q3D document, a Guideline for Elemental Impurities, which is anticipated to be implemented in early 2016.

The subject is of principle importance to the manufacturers of new drug products as they will be required to comply with the new elemental impurities standards either through thorough risk assessments or through testing. If the manufacturer’s compliance strategy involves testing, there are many things to consider with regards to selecting the correct analytical technique (atomic absorption, ICP emission spectroscopy, ICP mass spectrometry or XRF). 


Next month’s live webinar from Eastern Analytical Symposium & Exhibition (EAS) and Pharma Webinars will provide an understanding of the new standards and guidelines, what testing is required in order to comply with the spirit of the documents, how to perform a proper risk assessment, and how to perform suitable analytical measurements.

To be held on 8th April from 9:30-11:30am ET (New York), the webinar will include an overview of USP 232 and 233, and will review ICH Q3D. It will be provided by Tim L. Shelbourn, Research Scientist, Eli Lilly and Company, and a Member of the General Chapter Expert Committee, USP.