: This monograph generally does not apply to lozenges, oral pastes, or oral gums, nor to tablets for rectal or vaginal use (which have their own monographs like 1145 and 1164). Critical Quality Tests
The European Pharmacopoeia is a publication that contains a set of standards for the quality, purity, and strength of medicines. It is published by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which is a department of the Council of Europe. The Ph. Eur. is recognized as a standard for the quality of medicines in Europe, and its monographs are used by regulatory authorities, manufacturers, and control laboratories to ensure the quality of medicines. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Tablets are defined as solid dosage forms that are prepared by compressing a mixture of active pharmaceutical ingredients and excipients. The tablets must be uniform in size, shape, and weight, and must meet specific requirements for hardness, friability, and disintegration. : This monograph generally does not apply to