May take up to 60 minutes depending on the coating type.
If a tablet fails dissolution Stage 1 (e.g., 4 tablets pass, 2 tablets release 70% vs Q=75%), you may proceed to Stage 2 (12 more tablets) or Stage 3 (total 24 tablets). But failure of Stage 3 = batch destruction.
Monograph 0478, Tablets , is a general monograph in the European Pharmacopoeia (Ph. Eur.) that lays down mandatory quality standards for all solid oral dosage forms defined as tablets. It applies to uncoated, film-coated, and sugar-coated tablets, unless otherwise specified in an individual monograph.
| Parameter | Ph. Eur. 0478 | USP <701>/<711> | JP (General Tests) | | :--- | :--- | :--- | :--- | | Disintegration time (uncoated) | 15 min | 15 min (but often 30 min for large tabs) | 15 min | | Dissolution vessel volume | 900 mL (preferred) | 500, 900, or 1000 mL | 900 mL | | Friability acceptance | 1.0% (uncoated) | 1.0% (but 0.8% for high-use) | 1.0% | | Uniformity of dosage units | AV ≤ 15.0 (2.9.40) | AV ≤ 15.0 (identical via ICH Q4B) | AV ≤ 15.0 | European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
: To provide bulk and cohesive properties.
For any batch of tablets to be released to the market, it must comply with a series of analytical tests defined in the monograph and general chapters. These tests are the pillars of quality control.
: Formulations designed to be easily crushed by chewing before swallowing, avoiding the need for immediate liquid intake. May take up to 60 minutes depending on the coating type
The "Tablets -0478-" monograph sets out specific acceptance criteria for each test method. These criteria are designed to ensure that tablets meet the required standards for quality, purity, and strength.
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To comply with Ph. Eur. 0478, tablets must pass a rigorous battery of tests. These tests ensure that the physical characteristics of the tablet translate into reliable therapeutic performance. 1. Uniformity of Dosage Units Monograph 0478, Tablets , is a general monograph
The Ph. Eur. monograph for tablets (0478) specifies several key requirements that manufacturers must meet to ensure the quality of their products. These requirements include:
For a pharmaceutical manufacturer, is more than a technical document. It is the legal gateway to sell tablets in Europe. If your QC report claims "Conforms to Ph. Eur. 0478," you are legally declaring that every batch released meets the standards for:
The European Pharmacopoeia is a publication that contains a set of standards for the quality, purity, and strength of medicines. It is published by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which is a department of the Council of Europe. The Ph. Eur. is recognized as a standard for the quality of medicines in Europe, and its monographs are used by regulatory authorities, manufacturers, and control laboratories to ensure the quality of medicines.