Research Progress of Raman Spectroscopy and Imaging Techniques for the Pharmaceutical Analysis

Monitoring critical quality attributes in pharmaceutical manufacturing ensures that the final product meets specified requirements. Process analysis allows for appropriate modifications and customization of pharmaceutical design from formulation to production. The laborious sample presentation and throughput have stimulated the development of in-process spectroscopy methods for pharmaceutical analysis. Raman spectroscopy has demonstrated the unique advantages of rapid and non-destructive analysis, good interpretability, and effective moisture interference avoidance. The Raman imaging technique can obtain spatial and chemical information that is useful for characterizing drug quality. This article describes the applications of Raman spectroscopy and imaging techniques in pharmaceutical analysis. It covers the monitoring of crystal forms and particle size distribution, quantification of active pharmaceutical ingredients, evaluation of contents uniformity, prediction of dissolution profiles in solid preparations, identification of counterfeit drugs, and applications in reverse engineering and process analytical technology. Moreover, the challenges and prospects are proposed to facilitate the continued development of Raman spectroscopy and imaging techniques, providing necessary references for further research in this field.