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2.9.19. Particulate contamination: sub-visible particles – PDG revision of general chapter released for public consultation

European Pharmacopoeia
Pharmacopoeial harmonisation
20 May 2021
Strasbourg, France

A new, revised version of general chapter 2.9.19. Particulate contamination: sub-visible particles has been published in Pharmeuropa 33.2. In addition to applying to solutions for dialysis, the European Pharmacopoeia requires this test to be performed for liquid parenteral preparations (0520), sterilised water for injections (0169) and solutions for organ preservation (1264).

This new version is the result of lengthy and fruitful discussions with experts from the Japanese Pharmacopoeia and the United States Pharmacopoeia within the Pharmacopoeial Discussion Group (PDG). The three pharmacopoeias each made a significant effort to come to a consensus on an updated text that is now undergoing public consultation in all three regions.

The revised text drafted by the PDG presents a harmonised procedure for each of the analytical procedures described. As a result, the light obscuration particle count test now allows the use of sample volumes less than 5 mL depending on the instrument capability. Furthermore, the microscopic particle count test no longer requires at least 10 units to be combined for small volume preparations. A combination of fewer units for this test is permitted depending on instrument capability and sample properties.

All interested stakeholders are strongly encouraged to review the revision proposal and submit their comments before 30 June 2021.

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