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

The container label must include (per Ph. Eur. general notices and individual monograph):

The Ph. Eur. monograph 0478 ("Tablets") defines the quality standards and test methods for immediate-release tablet dosage forms intended for human use across member states. It provides mandatory requirements for identity, purity, content uniformity, mechanical integrity, dissolution, labeling, storage, and documentation. The monograph ensures tablets are safe, effective, and consistent from batch to batch, serving manufacturers, regulators, QC analysts, and pharmacists. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

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. The container label must include (per Ph