The European Pharmacopoeia (Ph. Eur.) Monograph 0478 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

  • Explicitly defines tablets as solid dosage forms containing a single dose of one or more active substances. It distinguishes between uncoated, film-coated, and non-functional coated tablets (excluding sugar-coated – see Chapter 2.9.1).
  • Provides a helpful list of common excipients (diluents, binders, disintegrants, glidants, lubricants).

Core Quality Tests (Compliance Criteria)

The heart of Monograph 0478 lies in its mandated quality control tests. These tests are designed to guarantee that every batch of tablets meets predefined criteria for identity, purity, and performance. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

Rigorous Uniformity Testing:

: For scored tablets, the monograph requires that break-marks be functional. If a tablet is meant to be split for a fractional dose, it must meet specific criteria for the uniformity of mass of the subdivided parts Modern Updates and Compliance The European Pharmacopoeia (Ph

  • This is mandatory for modified-release tablets (prolonged/delayed) and increasingly required for immediate-release tablets to ensure bioavailability.