European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- Jun 2026
Monograph 0478 begins by defining precisely what constitutes a "tablet." According to the Ph. Eur., tablets are solid dosage forms containing one or more active substances, with or without excipients, obtained by compressing uniform volumes of particles. The monograph explicitly covers a wide range of tablet types, including uncoated, film-coated, gastro-resistant (enteric-coated), and dispersible tablets. Importantly, it also addresses sublingual, buccal, and effervescent tablets, highlighting the versatility of the dosage form.
Would you like a side-by-side comparison with the USP or JP tablet monographs as well? European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
The European Pharmacopoeia (Ph. Eur.) Monograph 0478 defines the mandatory legal standards for the production, quality control, and testing of tablet dosage forms in Europe. It mandates specific tests for uniform dosage, disintegration (15 minutes for standard tablets), dissolution, and, if applicable, the subdivision of tablets to ensure patient safety and quality. For full details on the monograph requirements, visit EDQM . Monograph 0478 begins by defining precisely what constitutes
| Test | Ph. Eur. Reference | When required | Common Pitfall | |------|--------------------|---------------|----------------| | Appearance | Visual inspection | Always | Overlooking color variation from batch to batch | | Identification A+B | As per monograph | Always | Using same HPLC condition for assay and ID (not allowed unless specified) | | Uniformity of mass | 2.9.5 | If active ≥ 50% w/w or ≥ 25 mg per unit | Not performing it on 20 tablets individually | | Uniformity of content | 2.9.6 | If active < 50% w/w or < 2 mg per unit | Applying mass method incorrectly to low-dose tablets | | Dissolution | 2.9.3 | Default for immediate-release | Using wrong apparatus (paddle vs basket) without justification | | Disintegration | 2.9.1 | Only if monograph permits | Forgetting time limit (e.g., 15 min for uncoated) | | Friability | 2.9.7 | Only if in specification | Testing hygroscopic tablets at ambient humidity | 50% w/w or <
: To provide bulk and cohesive properties.