The European Pharmacopoeia (Ph. Eur.) is the authoritative standard for the quality control of medicines in Europe. is a general monograph , meaning it applies to the entire dosage form category rather than a specific chemical substance. It defines the fundamental standards for the manufacture, identification, testing, and storage of tablets intended for human and veterinary use.
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 European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-