European Pharmacopoeia Ph Eur Monograph Tablets 0478 Better [extra Quality] May 2026

Essay: The European Pharmacopoeia Monograph “Tablets” (0478) – A Pillar of Quality and Safety

Step 3: Process Analytical Technology (PAT)

• Disintegration (Chapter 2.9.1): Required for immediate-release tablets. The tablet must break down into particles within a defined time (e.g., 15 minutes for uncoated tablets) to allow for drug dissolution.
• Dissolution (Chapter 2.9.3): Required to demonstrate that the active substance is released from the tablet into solution. This is critical for modified-release tablets (sustained, delayed, or prolonged release).

Failure Criteria

: The batch fails if more than one mass is outside the 85-115% range, or if even a single mass falls outside 75% to 125% of the average. Implementation and Regulatory Context