European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478- Better -
European Pharmacopoeia (Ph. Eur.) Monograph 0478
The , titled "Tablets" (Compressi) , is the central general monograph establishing the mandatory quality standards for all tablet dosage forms in Europe. It provides the legal and scientific framework for their development, production, and marketing. Core Definition & Scope
Significance of the Monograph
Subdivision (Scoring)
: For tablets with break-marks, the efficacy of the mark is assessed by weighing subdivided parts. Not more than one out of 30 parts may fall outside 85% to 115% of the average mass. 4. Mandatory Pharmacopoeial Tests European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-