In this course that will take place at Bella Sky, Copenhagen, we will give you an overview of methods and regulatory requirements. Based on real life examples, we will go through commonly observed pitfalls in particle size determination that should avoided.
By far the most important physical property of particulate samples is particle size. Particle size determinations is routinely carried out across a wide range of industries and is a critical parameter in the manufacture of pharmaceutical products. Particle size has a direct influence on material properties such as reactivity, dissolution rate, stability, flowability and handling.
Particle size distribution should be known – and controlled! Ultimately, to protect patients, but also to avoid unpleasant surprises during manufacture. Measurement of particle size is not an exact technique and a “true” value does not exist. A range of analytical techniques is available for determination of particle size; these all have their strengths and weaknesses. In order to develop and validate analytical methods for determination of particle size, it is necessary to correlate several methods.