Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 100, Issue 4, Pages 1228-1259Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.22376
Keywords
solid dosage form; chemical stability; mass spectrometry; formulation; excipients; chromatography; drug degradation; pharmaceutical impurity
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Structure elucidation of pharmaceutical impurities is an important part of the drug product development process. Impurities can have unwanted pharmacological or toxicological effects that seriously impact product quality and patient safety. This review focuses on current analytical strategies for chemical and structural identification of pharmaceutical impurities. Potential sources and mechanisms of impurity formation are discussed for both drug substance and drug product applications. The utility of liquid chromatography-mass spectrometry (LC/MS) for providing structure-rich information is highlighted throughout this review. Other hyphenated analytical techniques including LC/nuclear magnetic resonance, gas chromatography/MS, and size-exclusion chromatography/chemiluminescent nitrogen detectors are also discussed, as LC/MS alone sometimes cannot reveal or confirm the final structures as required during dosage form development. (c) 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:1228-1259, 2011
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