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

Understanding Ph. Eur. Monograph 0478: The Standard for Tablets

These have separate monographs (e.g., 2066, 2067, etc.). European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

• The monograph tells what tests to do (e.g., assay by HPLC) but does not include validation parameters (linearity, accuracy, precision). Those are in Chapter 5.21, but a brief reminder would help.

Mastering the Standard: A Guide to Ph. Eur. Monograph 0478 for Tablets Understanding Ph