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.
... to continue reading you must be subscribed
