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Determination of Impurities in Pharmaceuticals: Why and How?

In: Quality Management and Quality Control - New Trends and Developments

Author

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  • Kung-Tien Liu
  • Chien-Hsin Chen

Abstract

The presence of impurities, particularly the API-related impurities, i.e., degradation-related impurities (DRIs) and interaction-related impurities (IRIs), may affect the quality, safety, and efficacy of drug products. Since the regulatory requirements and management strategies are required to be established and complied, sources of impurities shall be carefully classified prior to take subsequent steps such as development of analytical methods and acceptance criteria. Current international regulatory requirements for the management of impurities in pharmaceuticals were reviewed. Procedures for the identification of DPIs in pharmaceuticals, i.e., ethyl cysteinate dimer, (R)-N-methyl-3-(2-bromophenoxy)-3-phenylpropanamine, sestamibi, etc., using high-performance liquid chromatography tandem mass spectrometry (LC-MS/MS) were studied. Scheme for the establishment of analytical methods and acceptance criteria of process-related impurities (PRIs) and DRIs in accordance with the requirements of International Council for Harmonization (ICH) and algorithm to perform the identification of DPIs by using LC-MS/MS has been proposed. Practice of kinetic study to distinguish PRIs and DRIs, determination of the potential core fragments coupled with a predicted list of relevant transformations for conducting MS/MS scans, applications of stable isotope distribution patterns or natural abundances, practice of mass balance, etc., have been well demonstrated to justify the reliabilities of identification results.

Suggested Citation

  • Kung-Tien Liu & Chien-Hsin Chen, 2019. "Determination of Impurities in Pharmaceuticals: Why and How?," Chapters, in: Paulo Pereira & Sandra Xavier (ed.), Quality Management and Quality Control - New Trends and Developments, IntechOpen.
    • Handle: RePEc:ito:pchaps:179256
    DOI: 10.5772/intechopen.83849
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    More about this item

    Keywords

    pharmaceutical products; impurities; regulatory requirements; analytical strategy; structural identification; validation; verification; LC-MS/MS; kinetic study; stable isotope distribution patterns;
    All these keywords.

    JEL classification:

    • L15 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Information and Product Quality

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