Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D

Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada. ICH Q3D provides a means of assessment and control of 24 elemental impurities using the principles of risk management as detailed in ICH Q9. It establishes permitted daily exposure (PDE) limits for each element, expressed in µg/day, calculated using published toxicity data and set according to the route of administration. The elements are divided into three classes based on their toxicity and likelihood of occurrence with limits applicable to finished formulations based on a maximum dosage of 10g/day. Compliance is not directly applicable to excipients or the drug substance, however, USP <232> does state “elemental impurity levels present in drug substances and excipients must be known, documented, and made available upon request.

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Lusochimica S.p.A.

Lusochimica S.p.A. is an Italian manufacturer of bulk active ingredients for pharmaceuticals (API), having sales offices in Milan and two production plants in Lomagna and Pisa, whose production processes strictly comply with international cGMP standards. Founded in 1964 and belonging to Menarini Group since 1984, Lusochimica S.p.A. incorporated former Laboratori Guidotti Fine Chemicals division starting January 2009, as a result of restructuring of Fine Chemicals operations within Menarini Group.

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Lusochimica S.p.A.

Lusochimica S.p.A. is an Italian manufacturer of bulk active ingredients for pharmaceuticals (API), having sales offices in Milan and two production plants in Lomagna and Pisa, whose production processes strictly comply with international cGMP standards. Founded in 1964 and belonging to Menarini Group since 1984, Lusochimica S.p.A. incorporated former Laboratori Guidotti Fine Chemicals division starting January 2009, as a result of restructuring of Fine Chemicals operations within Menarini Group.

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