The European Pharmacopoeia (Ph. Eur.) Monograph 0478, (Compressi), defines the general quality, manufacturing, and testing standards for tablet preparations, including requirements for dissolution and mass uniformity. It specifies standards for various types, such as uncoated, coated, and gastro-resistant tablets, often requiring compliance with additional Ph. Eur. chapters. For the full text, see uspbpep.com
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Monograph 0478 mandates that tablets be stored in a way that protects them from:
Containers must be well-closed. If the tablets are sensitive to moisture, "tight" or "hermetic" containers may be required.
This guide is for informational purposes only. Always refer to the official current edition of the European Pharmacopoeia for legally binding requirements.
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. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
This is for informational purposes only. For medical advice or diagnosis, consult a professional. AI responses may include mistakes. Learn more tablets 0478e.pdf - uspbpep.com
European Pharmacopoeia (Ph. Eur.) Monograph: Tablets (0478)
The European Pharmacopoeia (Ph. Eur.) is a publication that sets standards for the quality, purity, and strength of medicines in Europe. The monograph for Tablets (0478) provides a comprehensive set of specifications for the testing and evaluation of tablets, which are a widely used dosage form for administering medicinal products.
Scope
This monograph applies to tablets, which are solid dosage forms containing one or more active pharmaceutical ingredients, compressed into a single unit. The monograph covers tablets that are intended for oral administration, including immediate-release, modified-release, and prolonged-release tablets. The European Pharmacopoeia (Ph
Definition
Tablets are defined as solid dosage forms that are prepared by compressing a mixture of active pharmaceutical ingredients and excipients. The tablets must be uniform in size, shape, and weight, and must meet specific requirements for hardness, friability, and disintegration.
Requirements
The Ph. Eur. monograph for Tablets (0478) specifies the following requirements:
Test methods
The monograph specifies the test methods that must be used to evaluate tablets, including:
Conclusion
The European Pharmacopoeia (Ph. Eur.) monograph for Tablets (0478) provides a comprehensive set of specifications for the testing and evaluation of tablets. The monograph covers a range of requirements, including appearance, average weight, uniformity of weight, hardness, friability, disintegration, and dissolution. By following these specifications, manufacturers can ensure that their tablets meet the necessary standards for quality, purity, and strength.
Monograph 0478 classifies tablets based on their release characteristics and site of action:
This test measures the tablet's ability to withstand abrasion during packaging and transport. A sample of tablets is rotated in a drum for a set time (usually 100 rotations). Moisture: Most tablets are hygroscopic
For immediate-release tablets, this test measures the time required for a tablet to break down into particles. The apparatus uses a basket-rack assembly moving up and down in a liquid medium.
