: This monograph generally does not apply to lozenges, oral pastes, or oral gums, nor to tablets for rectal or vaginal use (which have their own monographs like 1145 and 1164). Critical Quality Tests
Understanding Ph. Eur. Monograph 0478: The Standard for Tablets European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
To ensure patients receive the intended dose, the break-mark's efficacy must be assessed during product development. The test: break 30 tablets by hand, weigh one part from each, and check mass uniformity. Not more than one part can fall outside 85-115% of the average mass. : This monograph generally does not apply to
A "monograph" in this context is a collection of quality standards for a specific type of product. Monograph 0478 is a "general" monograph, meaning its requirements apply to all tablets that fall under its definition, regardless of their specific active ingredient. These requirements are legally binding within the European Union, mandated by EU Directives 2001/82/EC and 2001/83/EC, which state that marketing authorization applications must comply with Ph. Eur. texts. Consequently, the standards set forth in monograph 0478 are legally enforceable for any tablet product marketed within the EU, a fact that underscores its critical importance for pharmaceutical manufacturers. Monograph 0478: The Standard for Tablets To ensure
The monograph outlines a suite of tests to ensure quality and performance. These tests are performed on a sample of the batch.