Uncoated tablets must typically disintegrate in water within . Film-coated tablets are allowed up to 30 minutes .
: Assessed via general chapter 2.9.7 to ensure tablets do not crumble or break during processing or transport.
Ensures each tablet contains the correct amount of active substance, typically through Uniformity of Mass or Uniformity of Content . European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
Understanding how to apply the monograph in practice is crucial for manufacturers.
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). Uncoated tablets must typically disintegrate in water within
This guide provides a structured interpretation of the monograph’s requirements, covering definitions, production, testing, and acceptance criteria.
: Uncoated tablets must typically disintegrate within 15 minutes in water at 37°C. Coated tablets (non-film) are allowed up to 60 minutes. Ensures each tablet contains the correct amount of
While disintegration shows the tablet breaking apart, dissolution measures the rate at which the active substance actually enters the solution. This is a proxy for how the drug will be absorbed into the bloodstream. Specific limits for dissolution are usually found in the individual monograph for the specific drug substance. 4. Friability and Resistance to Crushing
However, the monograph does not apply in isolation. It must be read in conjunction with the general chapters of the Ph. Eur., particularly the and the General Chapter on Uniformity of Dosage Units (2.9.40) . This hierarchical structure ensures consistency across all monographs while allowing specific tests tailored to tablets.