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An insight into the presence of impurities in reference standards and their impact on mass spectrometry-based bioanalysis

    Ashok M Ghoghari

    *Author for correspondence: Tel.: +91 271 766 5555;

    E-mail Address: ashok.ghoghari@zyduslife.com

    Bioanalytical Laboratory, Zydus Research Center, Ahmedabad, 382210, Gujarat, India

    ,
    Harilal V Patel

    Bioanalytical Laboratory, Zydus Research Center, Ahmedabad, 382210, Gujarat, India

    &
    Mukul R Jain

    Bioanalytical Laboratory, Zydus Research Center, Ahmedabad, 382210, Gujarat, India

    Published Online:https://doi.org/10.4155/bio-2022-0138
    Free first page

    Papers of special note have been highlighted as: • of interest

    References

    • 1. Robinson TW, Jacobs A. Metabolites in safety testing. Bioanalysis 1, 1193–1200 (2009).
    • 2. US FDA. Guidance for Industry: Bioanalytical Method Validation. MD, USA (2018).
    • 3. EMA. Guidance on Bioanalytical Method Validation. London, UK (2011).
    • 4. ICH. ICH harmonized guideline: bioanalytical method validation and study sample analysis, M10 (2022). • Summarizes the bioanalytical method validation guidance published by various regulatory agencies and related articles on presence of impurities in standards.
    • 5. US Pharmacopeia. USP chapters <1086> impurities in drug substances and drug products. In:USP 41. US Pharmacopeial Convention, MD, USA (2018).
    • 6. ICH. ICH harmonized triplicate guideline: impurities in new drug substances, Q3A (R2) (2006).
    • 7. US FDA. Guidance for Industry, ANDAs: Impurities in Drug Substances. MD, USA (2009).