Combined Chromatographic and Spectrometric Approaches for Cleaning Verification of Small-Molecule Pharmaceutical Compounds in the Manufacturing Environment.

Cleaning verification (CV) is a critical step in the pharmaceutical manufacturing process to ensure unadulterated products are released to the patient. Recent advances in chromatographic CV techniques, such as liquid chromatography-ultraviolet detection (LC-UV), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography with charged aerosol detection (LC-CAD), and spectrometric methods for small molecule pharmaceuticals, are summarized and compared based on their sensitivity, specificity, robustness, versatility, and throughput. A CV workflow utilizing the abovementioned methods and visual verification is proposed. [ABSTRACT FROM AUTHOR]