The World Health Organization reports that 10.5% of all drugs in low- and mid-income countries are substandard or falsified products. Developing new, accurate experimental methods to evaluate drug production and the quality of the final drug product is essential. This study used naturally abundant δ2H, δ13C, and δ18O isotopic ratio mass spectrometry, allowing for the unique isotopic identification of 27 solid pharmaceutical drug products and 27 commonly used excipients. Stable light isotopic analysis is a powerful tool for specific chemical identification, enabling health authorities and pharmaceutical manufacturers to detect substandard and falsified drug products while maintaining the high quality of approved drug products.
Learning Objectives:
Understand the isotopic delta notation, why isotopic ratios are measured against certified reference materials, and why stable light isotopic analysis of pharmaceutical drug products and excipients does not require sample preparation before analysis
Demonstrate how isotopic ratio analysis reveals unique chemical information in pharmaceutical drug products and excipients
Understand how isotopic analysis can support health authorities and manufacturers in detecting falsified and substandard drug products, protecting against patent infringement, and evaluating supply lines to ensure high-quality drug products
