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

: Uncoated tablets must typically disintegrate within 15 minutes in water at 37°C. Coated tablets (non-film) are allowed up to 60 minutes.

Preparations for , which are covered by other monographs like Rectal preparations (1145) or Vaginal preparations (1164). Production Requirements

The European Pharmacopoeia (Ph. Eur.) is a publication that contains a set of monographs and general chapters that describe the official standards for medicines in Europe. The Ph. Eur. is published by the European Directorate for the Quality of Medicines & Healthcare (EDQM), which is a part of the Council of Europe. The Ph. Eur. is recognized as a standard for the quality of medicines in many countries, including all European Union member states. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-

The monograph outlines several "mandatory" tests that tablets must pass to be compliant. These include: Uniformity of Dosage Units

: Designed to dissolve in water with the release of carbon dioxide. : Uncoated tablets must typically disintegrate within 15

Before a tablet ever reaches a patient, it must survive manufacturing, bottling, shipping, and handling. This is where the physical attributes described in 0478 come into play.

Covered with layers of sugars, resins, or polymers. Production Requirements The European Pharmacopoeia (Ph

A specific requirement of 0478: "For tablets, the test for dissolution is a more stringent measure of bioavailability than disintegration, but it does NOT replace the need for impurity profiling."

This is perhaps the most critical safety test. It ensures that every single tablet in a batch contains the correct amount of the active ingredient. Compliance is typically demonstrated through:

: Ensures each tablet contains the correct amount of active ingredient. This is generally verified through Uniformity of Mass or Uniformity of Content .