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

The container label must include (per Ph. Eur. general notices and individual monograph):

This test measures the tablet's ability to withstand abrasion during packaging and transport. A sample of tablets is rotated in a drum for a set time (usually 100 rotations). European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

While not always a specific limit in the monograph, hardness is a critical in-process control (IPC). The tablet must be hard enough to handle but soft enough to disintegrate/dissolve. The container label must include (per Ph

Monograph 0478 does not specify which chemical identity test to use (that is left to the individual active substance monograph). However, it mandates that the must be capable of distinguishing the tablet from placebo. A sample of tablets is rotated in a

: 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