European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- [new] Jun 2026

Intended to be dissolved or dispersed in water before administration; must disintegrate within 5 minutes.

Disintegration measures the time required for a tablet to break apart into smaller particles under specific mechanical agitation in a fluid medium. Monograph 0478 establishes clear maximum disintegration time limits based on tablet type: Typically within 15 minutes in water. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: Formulated to ensure easy crushing by chewing before swallowing, maximizing patient adherence in specific demographics. Intended to be dissolved or dispersed in water

The establishes the legally binding quality, safety, and manufacturing standards for oral tablet dosage forms across 39 European countries. Managed by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , this general monograph serves as a regulatory cornerstone for pharmaceutical manufacturers, national control laboratories, and regulatory authorities. It guarantees that all tablets sold or distributed within the signatory states maintain rigorous and consistent chemical, physical, and microbiological properties. 1. Scope and Core Definition : Formulated to ensure easy crushing by chewing

Manufacturers must adhere to specific "Production" and "Test" sections to satisfy regulatory bodies like the European Directorate for the Quality of Medicines & HealthCare (EDQM) . 1. Disintegration Testing (General Chapter 2.9.1)

This detailed classification serves as the foundation for the monograph’s quality parameters.

: Ensures each tablet contains the correct amount of active ingredient. This is generally verified through Uniformity of Mass or Uniformity of Content .