78 FOOD & DRINK TECHNOLOGY
Changes to heavy metals detection
Pharmaceutical heavy metals detection now requires high- technology equipment.
T
he United States Pharmacopoeia (USP) test for heavy metals (USP
231) is to undergo a proposed change with replacement by spectroscopy methods in the new elemental impurities chapters, USP 232, 2232 and 233.
Te US Pharmaceutical Convention proposes that these changes are implemented by 1st December 2015. In the current European Pharmacopoeia (Ph Eur), the 2.4.8 heavy metals test will be replaced with two elemental impurities procedures. Tis is reflected in the general chapters 5.20, where limits are imposed for metal catalysts, and in 2.4.20, which provides suitable sample preparation and measurement techniques.
Fig.1. Companies need to invest in ICP and ICP-MS equipment to conduct in- house testing.
Tese changes will have an impact on the testing and development of drugs and
dietary supplements for consumption in the US and European markets. Te USP 231 test is currently a colourimetric procedure based on the precipitation of heavy metals that is only sensitive enough for certain elements (Pb, Hg, Bi, As, Sb, Sn, Cd, As, Cu and Mo). Te test is not specific, nor does it provide adequate measurement of the elements being tested for.
Te test was developed more than 100 years ago and since then, with the chemical synthesis of active pharmaceutical ingredients (APIs), the drug development process has changed.
Modern manufacturing In the manufacturing process, sources of heavy metals include those that are deliberately added to the process (such as catalysts), those that are
carried through a process that is conducted according to good manufacturing practices (undetected contaminants from starting materials or reagents, for instance), those coming from the process (for example, leaching from pipes and other equipment), and those that occur naturally (such as those from naturally derived plant or mineral sources).
Modern drug manufacture APIs involving the use of metal catalysts or metal processing equipment can become contaminated, as can the formulation.
Chromium and nickel are potential contaminants from modern stainless steel processing equipment and are not detected by USP 231.
Both the Ph Eur and the USP
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