Raw Material Identification by NIR Spectroscopy

This white paper discusses the application of Near-Infrared (NIR) spectroscopy for Raw Material Identification (RMID) in the pharmaceutical industry. It outlines the evolution of RMID sampling criteria, particularly the recent global regulatory shift mandating 100% material testing, which has necessitated the development of portable, user-friendly NIR instruments. The document details the advantages of receiving-point RMID, emphasizing its role in Quality by Design (QbD) and LEAN methodologies. The paper describes the configuration of the MicroNIR OnSite-W NIR handheld spectrometer for RMID, including the workflow for setting up the materials library and performing measurements. It also highlights the complementary nature of NIR and Raman spectroscopy in material qualification, particularly in assessing moisture content and particle size. The paper concludes by asserting the importance of NIR spectroscopy in enhancing efficiency and reliability in RMID processes, thereby reducing the burden on quality control laboratories.