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

: For identification and patient compliance. Key Quality Control Tests

: To ensure the tablet breaks apart in the digestive tract. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: 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 : For identification and patient compliance

: To provide bulk and cohesive properties. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

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:

The monograph mandates several standardized tests to verify the physical and chemical integrity of the dosage form. 1. Disintegration and Dissolution