European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- [hot] Jun 2026

The monograph outlines several mandatory tests that assess both physical integrity and chemical uniformity: European Pharmacopoeia - Background and Mission

Ph. Eur. 2.9.6 (or 2.9.40) If a tablet contains less than 2 mg or less than 2% (w/w) of an active substance, Uniformity of Mass is not sufficient . You must perform Uniformity of Content via an assay (usually HPLC) on 10 individual tablets. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

The European Pharmacopoeia (Ph. Eur.) is a publication that contains a set of monographs and general chapters that describe the official standards for medicines in Europe. The Ph. Eur. is published by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which is a part of the Council of Europe. The Ph. Eur. is recognized as a standard for the quality of medicines in many countries, including all European Union member states. The monograph outlines several mandatory tests that assess

This article provides an exhaustive technical breakdown of , covering its scope, analytical requirements (disintegration, dissolution, uniformity), official interpretation, and common pitfalls in Quality Control (QC) laboratories. You must perform Uniformity of Content via an

: Allowed up to 60 minutes (excluding film-coated, which are 30 minutes). Soluble/Dispersible : Must break down within 3 minutes . 2. Dissolution (General Chapter 2.9.3)

| Requirement | Details | | :--- | :--- | | | Tablets must be robust enough for handling and subsequent processing. This is assessed through tests like Friability of uncoated tablets (2.9.7) and Resistance to crushing of tablets (2.9.8) . | | Uniformity of Subdivided Parts (for Scored Tablets) | For tablets with break-marks used to split doses, the manufacturer must demonstrate that the subdivided parts are uniform. The test involves breaking 30 tablets, weighing one half from each, and ensuring no more than one mass falls outside 85-115% of the average mass. | | Microbiological Quality | Suitable measures must be taken to ensure microbiological quality throughout the lifecycle, in line with general chapter 5.1.4. |

The monograph distinguishes several categories of tablets based on their intended use or design. A summary of these categories, their definitions, and key considerations is provided in the table below: