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

Monograph 0478 classifies tablets based on their release characteristics and site of action:

A mandatory test (unless otherwise justified) to confirm the active substance is released at the right rate and time. 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. Monograph 0478 classifies tablets based on their release

Tablets must comply with standards for non-sterile preparations described in Ph. Eur. Chapter 5.1.4. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

The monograph emphasizes that the manufacturing process must ensure: