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

For solid dosage forms, the active substance must be released and absorbed to be effective. The monograph gives priority to the Dissolution Test (2.9.3) , which measures the percentage of drug released into a specified medium over time (e.g., 80% in 30 minutes). For rapidly dissolving tablets of highly soluble drugs, a Disintegration Test (2.9.1) may be substituted, where tablets are placed in a basket-rack assembly in water at 37°C and must disintegrate within a specified time (e.g., 15 minutes for uncoated tablets). For enteric-coated tablets, the monograph specifies two stages: resistance to disintegration in acidic medium (simulating stomach), followed by disintegration in neutral buffer (simulating intestine).

This is arguably the most critical safety and efficacy test. It ensures that each tablet in a batch contains the active substance within a narrow range (typically 85–115% of the label claim). The test is performed according to General Chapter 2.9.40, using either content uniformity (individual assay of 10 tablets) or mass variation (weighing tablets for potent drugs). Failure here indicates poor manufacturing mixing or compression, leading to underdosing (ineffectiveness) or overdosing (toxicity). European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

In the pharmaceutical world, the is the gold standard for quality control, and Monograph 0478 is the essential blueprint for anyone manufacturing or testing oral tablets. This general monograph defines exactly what a tablet is and sets the baseline requirements for its production and performance. What is Monograph 0478? For solid dosage forms, the active substance must