Under Monograph 0478, tablets are defined as They are obtained by compressing uniform volumes of particles or by other methods of manufacture (e.g., moulding, extrusion).
The , titled Tablets (Compressi) , is a legally binding general monograph that establishes essential quality standards for tablet dosage forms in Europe. As a "general monograph," it provides overarching requirements for production, testing, and labeling that apply to all tablets, unless a specific monograph for a particular drug provides different instructions. Scope and Definition
Intended to resist gastric fluid and release substances in the intestine. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
This monograph does not apply to lozenges, oral pastes, or oral gums, which are covered under other sections like Oromucosal Preparations (1807) . Primary Tablet Categories
Monograph 0478 mandates several critical tests to ensure batch-to-batch consistency: Under Monograph 0478, tablets are defined as They
Disintegration is a critical benchmark for how a tablet breaks down in the body. Standard limits include:
Whether you are a formulation scientist or a quality control specialist, understanding this monograph is essential for ensuring every batch meets rigorous safety and efficacy benchmarks. What is Monograph 0478? Monograph 0478, titled simply Tablets (Compressi) Scope and Definition Intended to resist gastric fluid
The monograph requires a visual description of the tablets (color, shape, markings). More critically, it mandates a specific identification test for the active substance(s), typically using High-Performance Liquid Chromatography (HPLC) or Infrared (IR) spectroscopy. This prevents mix-ups and ensures the correct drug is present.