The European Pharmacopoeia (Ph. Eur.) general chapter 5.20, titled Elemental impurities, is a crucial part of pharmaceutical quality control. This chapter incorporates elements from the ICH Q3D guideline, setting legally binding requirements for elemental impurities in pharmaceutical preparations, as referenced by the general Ph. Eur. monograph Pharmaceutical preparations. These regulations extend to extractable elements that may originate from plastic containers and closures used in pharmaceutical packaging.
While the scope of ICH Q3D and, by extension, Ph. Eur. 5.20, does not directly encompass the plastic materials themselves used in pharmaceutical containers, a risk-based approach is still essential. ICH Q3D clarifies that if a thorough review of container closure systems demonstrates a negligible risk of elemental impurities, further risk assessment may not be needed. To support this, Ph. Eur. Expert Group 16 has proactively developed a cutting-edge method for evaluating extractable elements from various plastic materials commonly used in the European pharmaceutical market.
This initiative led to the development of Ph. Eur. chapter 2.4.35 Extractable elements in plastic materials for pharmaceutical use. Initially published as a draft in Pharmeuropa, the finalized chapter focuses specifically on the methodology for testing extractable elements within plastic materials. Notably, the final version of Ph. Eur. 2.4.35 omits the originally proposed mandatory limits for these extractable elements. Instead, these limits will be provided as recommendations within a new general guidance document in section 5 of the Ph. Eur., further aligning with the principles outlined in chapter 5.20.
The official publication of Ph. Eur. Chapter 2.4.35 Extractable elements in plastic materials for pharmaceutical use is anticipated in Ph. Eur. Supplement 11.7, expected in September 2024. Following its release, references to Ph. Eur. 2.4.35 will be integrated into general chapters concerning specific plastic materials, commencing with new sections on Cyclo-Olefin Polymers (COP), Cyclo-Olefin Copolymers (COC), and Styrene Block Copolymers. This integration will ensure a consistent and comprehensive approach to managing elemental impurities in pharmaceutical products, building upon the foundational principles of Ph. Eur. 5.20.
