Technical breakthroughs for better understanding and characterization of chemical or biochemical process are necessary to meet today’s challenges posed to the pharmaceutical and fine chemicals industries. Proper integration of process analyzers and process automation together with the use of multivariate tools for design, data acquisition and analysis is critical and listed in Food and Drug Administration (FDA) guidance of Process Analytical Technology (PAT). Their use helps conduct information-rich experiments that respond to the need for increased process development throughput, downstream consistency and reliability.
Published and unpublished recent case studies were selected from the following:
- The trifluoroacetylation of a lactol derivative was investigated using real time in situ Fourier Transform Infrared (FTIR). ReactIR™ was used to determine the conditions which lead to high level of dimer impurity, help identify critical process parameters, and obtain kinetic information in real time.
- Real time calorimetry (RTCal™) helped evaluate the heat generation of an anionic acrylamide (ACM) inverse emulsion polymerization. This enabled the determination of differences in the rates of reaction of less inhibited acrylamide relative to standard acrylamide.
- The supersaturation of paracetamol during crystallization experiments was monitored in real time using in situ Fourier Transform Infrared (FTIR) and multivariate chemometric techniques for quantitative analysis. Integrating these tools into a computer controlled reaction vessel allowed a better control of experimental conditions, as well as a faster and more intuitive protocol to collect data points, build a calibration model, and apply the model to monitor supersaturation in real time.
Webinar Presenter
Your online presenter, Dominique Hebrault, has a Ph.D. in Organic Synthesis and has over 10 years experience in process development in the pharmaceutical and chemical industries using automated laboratory tools.
Your online presenter, Dominique Hebrault, has a Ph.D. in Organic Synthesis and has over 10 years experience in process development in the pharmaceutical and chemical industries using automated laboratory tools.
Related topics: PAT, Process Analytical Technology, Laboratory Automation, process analyzers, process automation, multivariate tools, FDA, Food and Drug Administration, ReactIR™, in situ reaction analysis, Fourier Transform Infrared Spectroscopy, FTIR, dimer impurity, critical process parameters, kinetics, real time calorimetry, RTCal™, polymerization, supersaturation, crystallization, chemometrics, quantitative analysis, In Situ FTIR Analytics, in situ reaction spectroscopy, iC IR, ReactIR™ 45m, reaction analysis software, organic synthesis , iC Kinetics