FOOD & DRINK TECHNOLOGY 79
define levels of heavy metal residuals allowable in the manufacturing process in a series of classes.
Currently the goal is to harmonise the USP, Ph Eur and International Conference on Harmonisation (ICH).
Te proposed USP methods would test for Class 1 (As, Cd, Hg and Pb) and Class 2 (Cu, Cr, Ir, Mo, Ni, Os, Pd, Pt, Rh, Ru and V) elemental impurities.
Te suggested Ph Eur methods would test for class 1A (Pt and Pd), Class 1B (Ir, Rh, Ru, Os), Class 1C (Mo, Ni, Cr, B), Class 2 (Cu and Mn) and Class 3 (Fe and Zn) elemental impurities.
Lastly, the proposed ICH methods would test for Class 1
(As, Pb, Cd and Hg), Class 2A (V, Mo, Se and Co), Class 2B (Ag, Au,Tl, Pd, Pt, Ir, Os, Rh and Ru), Class 3 (Sb, Ba, Li, Cr, Cu, Sn and Ni) and Class 4 (B, Fe, Zn, K, Ca, Na, Mn, Mg, W and Al) elemental impurities. Tese differ in range from the heavy metals detected by the traditional USP 231 method.
Te above changes will call for a paradigm shift in technology to achieve the required accuracy, range, specificity and limits of detection.
Sample preparation Te USP proposed 232 and 233 changes will require new methods of sample preparation, such as acid digestion followed by analysis using ICP and ICP-MS instrumentation.
Tis will require methodology expertise, as well as a broad depth of sample preparation knowledge.
Instrument set-up, what type of system is used for sample introduction and plasma discharge are all integral aspects of accurate and representative analysis that is fit for purpose.
Tese changes will entail a considerable investment by pharmaceutical companies in the drug development process. As it takes many years to bring a product to the marketplace, companies must be made aware of the proposed changes now and start to develop testing of their product to comply with future regulations.
Te new technology will
Terefore it is now the time for such companies to seek out a partner contract research organisation (CRO) with the capabilities, knowledge and resources to perform this for them.
Without any large capital investment required from the pharmaceutical company, the CRO partner can develop and validate methodology for the detection and quantification of the particular heavy metals used in the drug development process at a fraction of the cost of keeping the analysis in house.
Testing services International Laboratory Services (ILS) is one of the market leaders in the provision of contract laboratory pharmaceutical testing services in the UK, and it provides a wide range of cGMP-compliant chemical and microbiological testing to both the food and pharmaceutical industries.
For more information ✔ at
www.scientistlive.com/eurolab ILS Limited is based in Shardlow, Fig. 2. ILS provides a range of contract laboratory pharmaceutical testing services.
Derbyshire, UK.
www.ils-limited.co.uk www.scientistlive.com
involve validation of the methodology for each particular pharmaceutical API and/or formulation as required.
The impact on businesses For many small- to medium- sized organisations the changes will necessitate a considerable investment in training staff in the required technology and investment equipment, such as ICP and ICP-MS to perform this testing in-house.
Tis will remove important resources from the pharmaceutical value chain and limit the focus on future research and developments, which in turn could have a considerable impact on the pharmaceutical development market.
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