The monograph mandates several standardized tests to verify the physical and chemical integrity of the dosage form. 1. Disintegration and Dissolution
: To facilitate the manufacturing process.
: This test determines whether tablets break up within a prescribed time when placed in a liquid medium. For plain tablets, the standard limit is typically 30 minutes in water at European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
: For identification and patient compliance. Key Quality Control Tests
: To provide bulk and cohesive properties. The monograph mandates several standardized tests to verify
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:
: To ensure the tablet breaks apart in the digestive tract. : This test determines whether tablets break up
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
: A critical test for immediate-release tablets to ensure the active substance is released at an appropriate rate. Applicants must propose product-specific dissolution tests to confirm batch-to-batch consistency. www.edqm.eu European Pharmacopoeia - Background and Mission