Process Analytical Chemistry and Nondestructive Analytical Methods: The Green Chemistry Approach for Reaction Monitoring, Control, and Analysis

Abstract

This chapter is focused on nondestructive analytical methods based on vibrational spectroscopy. Following the tenets of process analytical chemistry, these analytical methods may monitor a manufacturing process as it occurs providing information on critical product quality attributes that is then used to control the process and achieve the expected product quality. The application of these principles to the improvement of pharmaceutical manufacturing has been termed process analytical technology, and is currently transforming the manner in which pharmaceutical processes are evaluated by regulatory agencies.Nondestructive methods may also be developed for use in a laboratory setting providing information after the product is manufactured. In both settings, the use of hazardous substances and consumption of materials is avoided in the analyses performed. These nondestructive methods present several advantages in comparison to the current laboratory‐based methods that require the use of reagents and transformation to clear solutions. The use of nondestructive testing often permits the simultaneous determination of chemical and physical properties in the materials analyzed. In some cases spectral changes may also be correlated with sensorial evaluation of product properties. These advantages have become a reality in industrial settings. Examples from the biodiesel, dairy, pharmaceutical, and polymer industries are discussed.

Real-Time Monitoring of Crystallization Processes Using a Novel Compact Composite Sensor Array

“…Since the launch of the process analytical technology (PAT) initiative by the FDA in 2004, PATs have been used to quantitatively or qualitatively monitor pharmaceutical manufacturing processes with the aim of improving process understanding and product quality control. − Here, crystallization is one of the most important unit operations. Over 90% of active pharmaceutical ingredients (APIs) require at least one crystallization step from solution as a process of purification, final crystal form selection, and/or particle size control while achieving an acceptable yield. ,,− Moreover, the crystallization of APIs is challenging, particularly when different crystal forms (e.g., polymorphs) can be produced for a particular compound. ,− ,, The control of the solid form is vital because different polymorphs may alter the API’s physicochemical properties, downstream processing, stability, and therapeutic efficacy. ,,,,, Due to these reasons, monitoring crystallization processes (batch and continuous) in real-time is key to ensure the desired critical quality attributes of the API are consistently obtained. ,,, In addition, process monitoring by PAT contributes to the advanced manufacturing paradigm of pharmaceuticals. ,,− …”

Lanthanum Exchanged Keggin Structured Heteropoly Compounds for Biodiesel Production

“…These properties are significant for any catalyst, as they play a role in the resistance against deactivation through solvents and thus improve their recycling potential [13]. It is worth mentioning that employing heterogeneous catalysts for biodiesel production based on HPAs is timely and extremely important, because these catalysts can be used in industry [14] for greener fuels [15] with easy separation between the target (biodiesel) and byproducts (mainly glycerol). Zhao et al [16] synthesized La-modified 12-molybdophosphoric acid samples with various La/Mo ratios and utilized them as catalysts for a fructose to lactic acid reaction.…”