European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- ((top))

This blog post provides an overview of the European Pharmacopoeia (Ph. Eur.) Monograph 0478, which serves as the legally binding standard for tablets marketed in signatory states.

The European Pharmacopoeia (Ph. Eur.) Monograph 0478 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 European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

Test methods

| Average mass (mg) | Percentage deviation | |-------------------|----------------------| | ≤ 80 | 10% | | 81 – 250 | 7.5% | | > 250 | 5% | This blog post provides an overview of the

Special cases and practical guidance

• Modified or delayed-release tablets: follow specific Ph. Eur. monographs or controlled-release guidance rather than 0478.
• Herbal or low-dose high-potency APIs: tailor content-uniformity approaches and containment measures.
• Orphan/complex formulations: justify deviations with pharmaceutical development data and regulatory agreement.

According to Monograph 0478, tablets are solid preparations each containing a single dose of one or more active substances. They are typically obtained by compressing uniform volumes of particles and may include excipients such as: Modified or delayed-release tablets: follow specific Ph