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

Monograph 0478 was first published in 1969 (as "Tabulettae") and last revised in (Ph. Eur. 11.3).

| Issue | Guidance | |-------|----------| | | Use a balance with appropriate precision (≥ 0.1 mg for < 50 mg tablets). | | Coated tablet friability | Not required by 0478, but may be requested by regulators if coating chips. | | Disintegration vs dissolution | Disintegration does not guarantee dissolution; dissolution is the definitive performance test. | | Uniformity of dosage units – mass variation eligibility | Check if active ingredient is ≥ 90% of core mass; otherwise, content uniformity is mandatory. | | Sugar-coated tablets disintegration | Time starts when tablet is placed in apparatus; coating must rupture within a few minutes. | European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

The provides the essential quality standards and legal requirements for Tablets (Compressi) within the European regulatory framework. Managed by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , this monograph ensures that solid oral dosage forms are safe, effective, and consistent across all signatory states. Definition and Scope of Monograph 0478 Monograph 0478 was first published in 1969 (as

The is the foundational quality standard for tablets intended for oral administration in Europe. Published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) , it establishes legally binding requirements for the definition, production, and testing of diverse tablet forms to ensure patient safety and therapeutic efficacy. 1. Scope and Definition | Issue | Guidance | |-------|----------| | |

The monograph specifies the test methods that must be used to evaluate tablets, including:

The monograph references strict testing methods to ensure that the variance between tablets is statistically insignificant. This is where the "mass variation" test meets the "content uniformity" test. If a tablet contains a tiny amount of potent API (like a hormone or an opioid), weighing the tablet isn't enough; chemists must assay the content of individual units. 0478 dictates when to use which method, ensuring that a patient never receives a "super-potent" or "sub-potent" dose.