European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- [NEW]

A specific requirement of 0478: "For tablets, the test for dissolution is a more stringent measure of bioavailability than disintegration, but it does NOT replace the need for impurity profiling."

Monograph 0478 mandates that tablets be stored in a way that protects them from: European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

While the global industry tries to harmonize via the ICH Q4B process, differences remain. A specific requirement of 0478: "For tablets, the

: Designed to react in water and release carbon dioxide before administration. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

: Tablets are solid preparations containing a single dose of one or more active substances. They are typically obtained by compressing uniform volumes of particles. Exclusions