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European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- May 2026

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:

: For identification and patient compliance. Key Quality Control Tests European Pharmacopoeia -ph. Eur.- Monograph Tablets -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 According to Monograph 0478, tablets are solid preparations

: 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 According to Monograph 0478

: To provide bulk and cohesive properties.

European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- May 2026

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