Regulatory Focus™ > News Articles > USP Releases Overhaul of Impurities Testing Standards

USP Releases Overhaul of Impurities Testing Standards

Posted 24 May 2012 | By

The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products.

The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures, outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure.

"Elemental impurities can occur naturally, be added intentionally, or be introduced inadvertently," explained USP in a statement.

The new standards expand upon and will eventually replace USP standard <231>, which sets limits for the presence of heavy metals in active pharmaceutical ingredients and excipients. USP said the standard, <231> Heavy Metals, was "no longer sufficiently sensitive to detect a number of impurities at levels known to be toxic," and needed to be replaced.

The standards will be made official on 1 December 2012, but enforcement of the standards will be delayed until 1 May 2014.

"We feel that these new standards have struck a good balance between the need to maintain the quality of medicines for the protection of patients and rational testing procedures and limits that can be readily applied by industry," concluded Anthony DeStefano, senior vice president for compendial sciences.

Read more:

USP - New Quality Standards Limiting Elemental Impurities in Medicines Announced

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