European Directorate for the Quality of Medicines & HealthCare - EDQM / European Pharmacopoeia: Ph. Eur. Supplement 10.6: updated dosage form monographs and general...

Ph. Eur. Supplement 10.6: updated dosage form monographs and general chapters Back News 04 February 2021 Strasbourg, France At its 168th session in November 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted revised versions of three dosage form monographs and two related general chapters, together with one new general chapter. While the revised texts cover a large number of medicinal products including all eye and ear preparations, and all large oral tablets and capsules above 18 mm in size, the new general chapter, Particulate contamination: sub-visible particles in non-injectable liquid preparations (2.9.53), mainly applies to certain eye preparations. A brief description of the main changes to the following dosage form monographs is given below: Eye preparations (1163) – New requirements concerning the test for sub-visible particle contamination have been added for eye drops and eye lotions. These requirements apply specifically for preparations used in a surgical setting or for the treatment of the injured eye. Where ophthalmic inserts are concerned, the text now stipulates that a suitable test to demonstrate the appropriate release of the active substances must be performed. Ear preparations (0652) – A new section on ear sprays has been created in order to specify clearly the tests to carry out for this category of ear preparations. Thus, uniformity of delivered dose (intra-container testing), number of deliveries per container and, for...