Application Note: A new crystallinity gauge: Real-time quantification and monitoring of crystallinity in pharmaceuticals

The measurement and quantification of crystallinity in pharmaceuticals is of vital importance, as this has a direct influence on the solubility and stability of the final drug product, affecting both efficacy and expiration…

Both environmental factors (e.g temperature, humidity) and manufacturing processes (e.g. grinding, milling, freeze drying) can dramatically affect crystal formation and/or breakdown into amorphous forms, and these processes are often dynamic on much faster timescales than most measurements can be taken. Therefore, having fast, reliable methods that can provide unambiguous determination of crystalline content is essential for chemical process development, formulation, stability testing and material characterisation. 

To date, there has been a lack of process analysis instruments that can provide both adequate sensitivity and a timely response for measurements and monitoring of crystalline content. A new Raman-based platform that provides real-time crystallinity measurements with superior sensitivity is now available.