Impurities pharmaceutical drug candidates

Alsante KM, Friedmann RC, Hatajik TD, Lohr LL, Sharp TR, Snyder KD, Szczesny EJ. Degradation and impurity analysis for pharmaceutical drug candidates. In Ahuja S, Scypinski S, eds. Handbook of Modern Pharmaceutical Analysis. Vol. 3. Separation Science and Technology. Academic Press, 2001 85-172. 

Alsante, K.M. Hatajik, T.D. Lohr, L.L. Sharp, T.R. Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates, part I. Am. Pharm. Rev. 2001, 4 (1), 70-78. 

Alsante, K., Friedmann, R., Hatajik, T., Lohr, L., Sharp, T., Snyder, K. and Szczesny, E. Degradation and Impurity Analysis for Pharmaceutical Drug Candidates. In Handbook of Modern Pharmaceutical Analysis, Ahuja, S. and Scypinski, S. (Eds.), Academic Press, San Diego, 2001. 

Chapter 14 provides practical guidance with case studies on isolating and characterizing process-related impurities and degradation products for pharmaceutical drug candidates. The case studies utilize isolation or synthesis in conjunction with mass spectral and NMR characterizations. A collaborative multiple disciplinary strategy has been found to be the most efficient way to solve impurity/degradation product problems. 

DEGRADATION AND IMPURITY ANALYSIS FOR PHARMACEUTICAL DRUG CANDIDATES... 

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