The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)
The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for injection, infusion or implantation.
The monograph has been modernised to meet current testing requirements e.g. for (sub-)visible particles, bacterial endotoxins, uniformity and release, particularly as applied to liquid parenteral preparations.
The monograph also refers to the newly elaborated informative non-mandatory chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles. The requirements for the test method are laid down in chapter 2.9.20, which is also under revision, and a revised text is planned for publication in 2019 (a draft was published in Pharmeuropa 30.2).
The new text highlights the many sources of particulate contamination and states that every effort should be made to avoid their presence.
The two texts have been published for public consultation in Pharmeuropa 30.4 (October issue) and the commenting period ends on 31 December 2018.