“Near-Infrared Study: A Modern Approach to Non-Invasive Analysis”

Abstract

The drug development process is a complex and time-intensive endeavor involving the discovery, laboratory testing, preclinical studies, clinical trials, and regulatory approval of new therapeutic agents. Ensuring drug products meet stringent criteria for quality, safety, and efficacy is essential for achieving optimal therapeutic outcomes. A critical aspect of this process is analytical chemistry, which plays a pivotal role in identifying, separating, and quantifying chemical constituents in both herbal and synthetic drug formulations. Analytical method development is the strategic formulation of experimental procedures that allow for the effective analysis of drug substances and products. These methods are vital for confirming the identity, purity, potency, and structural characteristics of pharmaceutical compounds. Among various analytical tools, near-infrared spectroscopy (NIRS) has gained significance for its non-destructive analysis capabilities, particularly in the 1100–2500 nm range. Although NIR signals are weaker due to low molar absorptivity and overlapping bands, the technique offers deep sample penetration and high-throughput screening when combined with chemometric techniques. This integration enables robust data interpretation, facilitating efficient quality control and validation in pharmaceutical manufacturing under current Good Manufacturing Practices (cGMP).