Isolation and Identification of Process Related Impurities and Degradation Products from Pharmaceutical Drug Candidates , Part I

@inproceedings{Alsante2002IsolationAI,
  title={Isolation and Identification of Process Related Impurities and Degradation Products from Pharmaceutical Drug Candidates , Part I},
  author={Karen M. Alsante and Todd D. Hatajik and Linda L. Lohr and Thomas R. Sharp},
  year={2002}
}
The objective of this two-part review article is to provide guidance for isolating and identifying process related impurities and degradation products from pharmaceutical drug candidates. The identification of degradation products can provide an understanding of impurity formation and define degradation mechanisms. If the identification process is performed at an early stage of drug development, there is adequate time for improvements in the drug substance process and drug product formulation… CONTINUE READING
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