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

Monograph 0478 also provides additional requirements for specialized tablet types:

: A critical test that measures how the active substance is released into a liquid medium over time. Ph. Eur. 0478 mandates a suitable dissolution test unless a disintegration test is otherwise justified. Disintegration (2.9.1) European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

Monograph 0478 mandates several critical tests to ensure batch-to-batch consistency: European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: Ensures each tablet contains the correct amount of active ingredient. This is generally verified through Uniformity of Mass or Uniformity of Content . European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-