Particle-characterization data is central to the development, manufacture, and quality control of pharmaceutical products. The characteristics of a pharmaceutical’s composite particles can affect the product in many ways, including by influencing drug efficacy and stability, as well as how the product behaves during processing. When considering the importance of particle characterization, the International Conference on Harmonization’s (ICH) Q6A guideline on specifications is a useful starting point because it identifies potentially important particle variables, including polymorphic form, enantiomeric purity, and particle size and distribution. The guideline also provides a decision tree to help determine when related testing is required.
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