Recent applications of near infrared to pharmaceutical process monitoring and quality control.

Abstract

NIR is a rapid, non-destructive analytical technique that leverages the absorption properties of molecules in the near-infrared region. This technology has become indispensable in the pharmaceutical industry due to its efficiency in analyzing solids, liquids, and various pharmaceutical preparations across numerous applications, including drug discovery, process monitoring, and quality control. With the advent of portable NIR instruments, the technology has gained a pivotal role in PAT, optimizing manufacturing processes and ensuring consistent product quality for real-time product release. This review reports on the remarkable versatility of NIR spectroscopy in the pharmaceutical field, covering a wide range of qualitative determinations, such as sample identification, crystal morphology, and eutectic analysis. It also addresses the quantitative analysis of samples and in-line applications in continuous manufacturing processes, including granulation, drying, tableting, and coating. The fundamentals of NIR spectroscopy, as well as its applications in botanical and biological products, are discussed. Additionally, the review examines the prospects and challenges associated with using NIR spectroscopic techniques. NIR spectroscopy served as an effective and powerful tool for both qualitative and quantitative analysis of pharmaceuticals and for monitoring continuous production.