After several years of proposals and discussion, the US Pharmacopoeia is closing in on implementation of new procedures for analysis of elemental impurities in pharmaceutical products. While there is no doubt that the methods detailed in Chapters <232> and <233> are more precise and accurate than those of the existing Chapter <231>, there have been concerns expressed by manufacturers that have held up implementation of the changes.
In June 2013, two working groups of the USP Elemental Impurities Implementation Advisory Group convened to discuss the challenges manufacturers will face in implementing the standards, and to evaluate issues for manufacturers whose products are especially affected by the elemental impurities standards. The resulting proposals are to be reviewed by the Expert Committee in October 2013 and as a result an appropriate date for mandatory introduction of 1 December 2015 has now been recommended.
While manufacturers may have concerns over implementation, from an analytical perspective, and indeed from the perspective of patient safety, it is clear that the methods detailed in the current Chapter <231> are in need of updating.
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