The monograph includes a "Tablets that are hygroscopic" clause, requiring testing at controlled humidity (e.g., 50-60% RH) – a nuance many other standards ignore. This prevents tablets that crumble in a bottle after three months in a humid climate.
While uniformity of mass indirectly assures content uniformity for potent drugs where the active substance constitutes a large proportion of the tablet, many modern drugs are highly potent (e.g., levothyroxine, digoxin). For such tablets, monograph 0478 mandates direct assay of 10 individual tablets. The acceptance value must be ≤15.0. This test is arguably the most important for patient safety, as it directly verifies that each patient receives the correct dose. european pharmacopoeia ph eur monograph tablets 0478 better
Microbiological Quality
in water. Orodispersible and soluble tablets generally have a limit of Dissolution : A suitable dissolution test (e.g., The monograph includes a "Tablets that are hygroscopic"