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Outcome of the 162nd Session of the European Pharmacopoeia Commission

30/11/2018 Strasbourg, France

At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts.

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Modification of the structure of Section 3. Materials and containers for the 10th Edition of the Ph. Eur.

29/11/2018 Strasbourg, France

The European Pharmacopeia (Ph. Eur.) includes a Section 3. on materials for containers (Subsection 3.1) and containers (Subsection 3.2). For historical reasons, the general chapters of this Section 3. include texts on primary packaging, as well as on medical devices. To clarify the...

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Public Consultation for Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)

06/11/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on two major texts for the testing of parenteral drug products. The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for...

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Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations

30/10/2018 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated...

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Pharmacopoeial Discussion Group Achievements

22/10/2018 Strasbourg, France

The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.

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