TEST METHODS USED DURING DEVELOPMENT OR MANUFACTURE

Overview

The International Pharmacopoeia has a Supplementary Information section which provides detailed guidance on various test methods used in pharmaceutical development and manufacturing. It includes procedures such as measuring bulk and tapped density of powders, tablet friability, resistance to crushing, and softening time determination for lipophilic suppositories. These methods are essential for ensuring the physical and mechanical properties of pharmaceutical products meet quality standards.

Additionally, this section offers recommendations for specific quality requirements, such as the use of plant-derived artemisinin as a starting material in antimalarial API production. By addressing these specialized test methods and materials, the section supports manufacturers and quality control professionals in maintaining the integrity and efficacy of medicines.

Link to Document

TEST METHODS USED DURING DEVELOPMENT OR MANUFACTURE