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Pharmscience is a GMP based consultancy located in Melbourne, Australia. Pharmscience provides GMP services and products to pharmaceutical and veterinary companies in Australia and Asia. The Pharmscience Newsletter is well known to many manufacturers.

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Elemental Impurities

USP <231> has included a metals screening test as part of raw material testing for many decades. This test is a wet chemical method based on precipitation of metallic sulphides out of an aqueous solution. The test solution result is then visually compared with a test done with a standard lead solution. The B.P. includes an identical test for metallic impurities. In recent years it has been shown that such precipitation reactions often have limited accuracy and can give false negative results. The limitations of this test have been the subject of various presentations and scientific papers. It has been acknowledged that instrumental test methods, like ICP-MS and ICP-OES are far superior and more reliable and more sensitive than the existing precipitation methods. ICP-OES is a powerful technique allowing determination of up to 70 elements in one sample at levels from ppm down to parts per trillion. The USP has been developing two new Chapters for Elemental Impurities:
<232> Elemental Impurities – Limits
<233> Elemental Impurities – Procedures
The four most toxic metallic contaminants are Cadmium, Lead, Inorganic Arsenic and Inorganic Mercury. The dose form the raw material is to be used in is also taken into account; limits for raw materials to be used in parenteral products are 10% of the limits proposed for oral products. Speciation of some elements is being reviewed; both Mercury and Arsenic can exist as inorganics or as part of an organic complex. Both Arsenic and Mercury are more toxic when present as inorganic contaminants. ICH Q3D has an Expert Working Group (EWG) that is looking at Limits for Elemental Impurities. It appears to us as if ICH Q3D limits are similar to those proposed in USP <232>.
Go to:; this hyperlink provides the current status of the new initiatives at USP for Elemental Impurities. This link will provide extra hyperlinks to recent discussion on this topic in the USP Pharmaceutical Forum. These new initiatives on Elemental Impurities are not yet finished but from our reading it appears as they could be finalised and incorporated into USP by September 2013.

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