Access to relevant physicochemical data is a known enabler of rapid pharmaceutical product development. Many APIs show poor solubility and bioavailability. Knowledge of the formulation and API microstructure is therefore critical to ensure effective product development. Within this, API particle size analysis is well-established as part of the characterization toolbox.
But how do you know if your measurement of particle size is accurate enough? Indeed, what is the ‘true’ value for the particle size of an API or excipient which should be used to fine-tune preclinical development and set product specifications? Should you even try to define this?
In this webinar, John Gamble, Principal Scientist at Bristol Myers Squibb, and Paul Kippax, Sector Director at Malvern Panalytical, argue that accuracy of particle size measurement is not a definable characteristic. Instead, they propose that you should seek to define the ‘appropriateness’ of a measurement, in line with the critical quality attributes (CQA) of the material being characterized.
Join us to explore:
- Why particle size analysis should prioritize appropriateness over accuracy
- What this means for laser diffraction method development
- How to implement image-based particle characterization approaches
- Strategies for integrating these approaches into your workflow