European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- May 2026

: To provide bulk and cohesive properties.

: To ensure the tablet breaks apart in the digestive tract. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: This test determines whether tablets break up within a prescribed time when placed in a liquid medium. For plain tablets, the standard limit is typically 30 minutes in water at : To provide bulk and cohesive properties

The monograph mandates several standardized tests to verify the physical and chemical integrity of the dosage form. 1. Disintegration and Dissolution For plain tablets, the standard limit is typically

: To facilitate the manufacturing process.

The provides the essential quality standards and legal requirements for Tablets (Compressi) within the European regulatory framework. Managed by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , this monograph ensures that solid oral dosage forms are safe, effective, and consistent across all signatory states. Definition and Scope of Monograph 0478