European Pharmacopoeia Ph Eur Monograph Tablets 0478 Better Jun 2026

Uncoated tablets must generally disintegrate within 15 minutes in water at

Impurities and Related Substances

Requires testing a random sample of 20 tablets. Compliance is achieved if no more than 2 individual masses deviate by more than the specified percentage from the average mass, and none deviate by more than double that percentage.

The monograph mandates good manufacturing practices, including taking measures to ensure tablets possess suitable mechanical strength. This is typically verified using and resistance to crushing (2.9.8) tests.

Digital Reporting and Data Integrity

There it was. A hairline fracture, invisible to the naked eye, just above the paddle blade. At 75 rpm, the shaft would flex by less than a millimeter. But that millimeter was enough to create a micro-vortex that spun the disintegrating tablet away from the probe, making the dissolution appear slower.

This test measures the rate at which the active substance is released into a liquid medium. It serves as a proxy for how the drug might behave in the digestive tract. Disintegration:

“You see,” she said, holding up the broken metal piece, “monograph 0478 isn’t a recipe for tablets. It’s a story about why every single word matters. The mass, the time, the temperature, the centering of the paddle . It’s a system. If you break one sentence, the whole story falls apart.”

More than 1 part is outside the 85%–115% range, OR any single part is outside the 75%–125% range. 3. Specific Tablet Categories

: Solid units meant to dissolve smoothly or disperse rapidly in water prior to administration.

Uncoated tablets containing acid substances and carbonates which react rapidly in water to release carbon dioxide. Soluble and Dispersible Tablets:

If you are filing a Marketing Authorization Application (MAA) in Europe, your dossier must reference the current version of 0478 (updated annually in April). The EDQM frequently revises 0478 to include new dosage forms like orodispersible films and mini-tablets.

The Revised Ph. Eur. Chapter Tablets notes that significant updates were implemented starting with and have continued through the 11th edition. Further policy changes established by the European Pharmacopoeia Commission now require specific dissolution or disintegration tests for nearly all immediate-release medicinal product monographs.