Monograph 0478 has a profound impact on the pharmaceutical industry and regulatory bodies like the European Medicines Agency (EMA) and national authorities. It provides the legal basis for quality control during development, production, and marketing. It also serves as the benchmark for when testing marketed products.
Includes film-coated (disintegration < 30 min) and other coated types (disintegration < 60 min). European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
The monograph begins with a precise definition of what constitutes a "tablet." According to Ph. Eur. 0478, , obtained by compressing uniform volumes of particles or by another suitable manufacturing technique, such as extrusion, moulding or freeze-drying (lyophilisation). Monograph 0478 has a profound impact on the
serves as the authoritative, legally binding framework dictating the production, testing, and quality standards for oral tablets across Europe. Managed by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , this general dosage form monograph establishes the compliance floor that pharmaceutical manufacturers must meet to secure and retain marketing authorizations. 1. Scope and Core Definition uniformity of weight
Disintegration is a critical benchmark for how a tablet breaks down in the body. Standard limits include:
Monograph 0478 also provides additional requirements for specialized tablet types:
The European Pharmacopoeia (Ph. Eur.) monograph for Tablets (0478) provides a comprehensive set of specifications for the testing and evaluation of tablets. The monograph covers a range of requirements, including appearance, average weight, uniformity of weight, hardness, friability, disintegration, and dissolution. By following these specifications, manufacturers can ensure that their tablets meet the necessary standards for quality, purity, and strength.