European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- Jun 2026

The Ph. Eur. monograph for Tablets - 0478 provides a comprehensive description of the requirements for tablets, including their definition, composition, manufacturing process, and testing requirements. The monograph applies to tablets that are intended for oral administration, and it covers a wide range of tablet types, including immediate-release, modified-release, and extended-release tablets.

Beyond Europe, the monograph serves as a reference for the World Health Organization (WHO), the International Pharmacopoeia, and regulatory bodies in countries like Australia, Canada, and Japan. Many manufacturers globally design their tablet production processes to meet Ph. Eur. 0478 criteria to facilitate entry into the European market. The monograph also evolves; recent revisions have incorporated stricter limits for nitrosamine impurities (via cross-reference to general chapter 2.5.42) and updated dissolution apparatus calibration requirements.

The "Tablets -0478-" monograph is a general monograph that applies to all tablets, unless a specific monograph exists for a particular product. This monograph was introduced to provide a comprehensive framework for the evaluation of tablets, taking into account their physical, chemical, and microbiological properties. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: Mandatory for tablets where the API comprises less than 2 mg or less than 2% of the total tablet mass. 4. Subdivision of Scored Tablets

Usually within 3 minutes. Orodispersible tablets: Within 3 minutes. D. Friability of Uncoated Tablets (2.9.7) The Ph

Monograph 0478 applies specifically to . These are obtained by compressing uniform volumes of particles or particle aggregates generated through granulation methods. Exclusions and Boundaries

Formulations such as vaginal tablets, implants, or those intended for other routes must comply with their specific target monographs (e.g., Ph. Eur. Monograph Vaginal Preparations (1164) ). 2. Classification of Tablets Covered under Monograph 0478 The monograph applies to tablets that are intended

The monograph dictates that the excipients used must be safe, non-toxic, and must not adversely affect the therapeutic efficacy or bioavailability of the active pharmaceutical ingredient (API). Excipients typically include diluents, binders, disintegrants, glidants, lubricants, and coloring or flavoring agents. Minimizing Microbial Contamination

Control active substance release behavior throughout the digestive tract. Key Quality Control and Physical Testing Requirements