Ph. Eur. 2.9.5 This is the "20 tablets weighed" test.
The European Pharmacopoeia Monograph for Tablets (0478) is far more than a technical document; it is a sophisticated quality management tool. By mandating tests for uniformity, disintegration, dissolution, and mechanical strength, it transforms a simple compressed powder into a predictable, safe, and effective medicine. It protects patients from dose dumping, poor absorption, and fragile products, while providing manufacturers with clear, legally enforceable specifications. As pharmaceutical science advances—towards personalized doses, 3D-printed tablets, and complex modified-release profiles—Monograph 0478 will continue to be revised and expanded. Yet its core mission remains unchanged: to ensure that every tablet, whether taken in a London hospital or a rural pharmacy in Greece, meets the highest possible standard of quality. In doing so, Ph. Eur. 0478 exemplifies the very essence of pharmacopoeial science: trust through testing. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
This monograph does not apply to lozenges, oral pastes, or oral gums, which are covered under other sections like Oromucosal Preparations (1807) . Primary Tablet Categories The European Pharmacopoeia Monograph for Tablets (0478) is
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: Measures the time required for a tablet to break up into smaller particles in a liquid medium. Uncoated tablets typically must disintegrate within 15 minutes , while coated tablets may have longer allowances.