Nondestructive techniques in pharmaceutical drug product characterization

Abstract

Pharmaceutical product development involves multiple steps; therefore, product quality must be assessed to ensure robustness and acceptance. Raw components, production methods, and ambient circumstances yield a highly variable end product with low batch-to-batch consistency. Although end testing is performed to ensure product quality yet intermediate quality checks are limited. Nondestructive techniques like Terahertz, near-infrared, X-ray, and Raman spectra are common tools for in-line quality check and real-time data monitoring. Handheld devices based on these analytical techniques also help in identifying the counterfeit drugs products. This review has discussed modern regulatory thinking on use of nondestructive tools in pharmaceutical quality monitoring.

Keywords: Non-destructive techniques; analytical characterization; critical quality attributes; pharmaceutical quality; spectroscopy.