To optimize drug delivery and processing, APIs are combined with several functional excipient categories:
The is the definitive, legally binding standard that dictates the manufacturing, quality control, and regulatory compliance requirements for tablets intended for oral administration across all signatory states of the Council of Europe . Maintained by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , this general monograph serves as a foundational blueprint for pharmaceutical manufacturers worldwide who wish to market solid oral dosage forms in Europe. Scope and Definition of Monograph 0478 European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-