Analytical Services: Overcoming challenges in particle size measurement by laser diffraction technique

Event: Landolakes Confernce – Strategies for Analytical Excellence
Speakers: Kalyan Poturi, Noel Hamill, Catherine McClorey and Linda McCausland
Introduction:

Increasing numbers of API’s are being discovered through use of high throughput screening, leading to larger lipophilic molecules with poor solubility characteristics. Therefore, the impact of particle size on bioavailability has become much more important and as a result, the particle size distribution of API is a critical quality attribute for many new drugs.  The poster details some parameters and conditions that should be considered during method development and validation for particle size distribution assessment by laser diffraction. This is illustrated by a case study where a single method was developed for both API and drug product for a drug with particle size distribution as a critical quality attribute.