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

The European Pharmacopoeia (Ph. Eur.) Monograph 0478, (Compressi), defines the general quality, manufacturing, and testing standards for tablet preparations, including requirements for dissolution and mass uniformity. It specifies standards for various types, such as uncoated, coated, and gastro-resistant tablets, often requiring compliance with additional Ph. Eur. chapters. For the full text, see uspbpep.com

: Since January 2018, revised standards mandate a suitable dissolution test for immediate-release forms unless otherwise justified. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

The monograph specifies the test methods that must be used to evaluate tablets, including: The European Pharmacopoeia (Ph