15/16 November 2023
The recently proposed new Ph. Eur. Chapter 2.4.35. Extractable elements in plastic materials for pharmaceutical use has been republished in Pharmeuropa 32.3. The text was initially published in Pharmeuropa 32.2 (comment deadline: June 30, 2020).
The EDQM has decided to prolong the comment period for the three draft chapters on COC, COP and 2.4.35 until September 30, 2020 to give all stakeholders sufficient time to comment. In addition, supporting information relevant to the general chapter has been released in Pharmeuropa. It is noted that "elemental impurities in plastic materials are not directly within the scope of the existing texts on elemental impurities" (e.g. ICH Q3D and Ph. Eur. 5.20 Elemental Impurities). However, "their impact on the quality of the containers produced from these materials is nonetheless to be taken into account".
Following the implementation of the ICH Q3D guideline, plastic materials for pharmaceutical use currently on the European market were re-analyzed for their content of extractable elements. The data obtained by ICP-MS confirmed that plastic materials can have a unique extractable elemental impurity profile. However, 10 elements were common for the materials tested. Thus, the new general chapter 2.4.35 provides limits for these 10 elements and the analytical procedure for their determination.
As a start, a cross-reference is included in the proposed new general Ph. Eur. chapters on COP (Cyclo-olefin polymers, 3.1.16) and COC (Cyclo-olefin copolymers, 3.1.17). According to the supporting information, it is further expected to revise all existing Ph. Eur. general chapters on plastic materials to delete the heavy metals test and to perform the tests on target elements according to the new Ph. Eur. chapter 2.4.35.
In comparison, the new USP Chapter <661.1> Plastic Materials of Construction states: "it is being left up to the material user to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished".
Furthermore, the ICH is currently working on a new ICH Q3E Guideline "Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics". The topic was endorsed by the ICH Assembly in June 2019, and an informal Working Group is being established to develop a concept paper.
More information can be found on the Pharmeuropa website.