Monograph 0478 mandates that tablets be stored in a way that protects them from:
General Monograph 0478, titled "Tablets," is a foundational quality standard within the European Pharmacopoeia (Ph. Eur.). The European Pharmacopoeia is the primary source of official quality standards for medicines and their ingredients in Europe, providing a legal and scientific basis for quality control throughout a product's lifecycle. European Pharmacopoeia -ph. Eur.- Monograph Tablets -0478-
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). Monograph 0478 mandates that tablets be stored in
Prevent die-wall friction during high-speed compression. This test measures the tablet's ability to withstand
Often colloquially referred to as "hardness" testing, this evaluates the diametral force required to crush the tablet. While the monograph requires manufacturers to measure this property to ensure structural integrity, specific numerical limits are usually defined in the individual substance monographs rather than the general 0478 text. 4. Specific Requirements by Tablet Type
The "Tablets -0478-" monograph is essential for manufacturers, regulators, and control laboratories involved in the development, production, and quality control of tablets. The monograph provides a comprehensive framework for evaluating the quality of tablets and ensures that medicinal products available to patients in Europe meet the required standards.
The monograph requires a visual description of the tablets (color, shape, markings). More critically, it mandates a specific identification test for the active substance(s), typically using High-Performance Liquid Chromatography (HPLC) or Infrared (IR) spectroscopy. This prevents mix-ups and ensures the correct drug is present.