lthough the risk factors for heavy metal contamination have altered
dramatically, standard methods for their determination and control have
changed little for more than 100 years,still relying on wet chemistry and interpreting color changes.
But now, new guidelines from the United States Pharmacopeia (USP) and the International Council
on Harmonization (ICH) are on the way. They take advantage of the huge advances in analytical science in recent years and demand accurate, reliable testing. It is a huge step-change in how trace elements are analyzed in pharmaceutical and nutraceutical products, and the
increased precision will provide a much higher degree of patient protection.
Patient safety is the number one priority for everyone engaged in making medicines, and the new
guidance has been welcomed. However, the increasing complexity of today’s analytical techniques does
throw up challenges, particularly for smaller pharma companies and generics manufacturers who may be faced with setting up new labs dedicated to trace element analysis, with all the associated equipment and training needs.
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