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Pharmaceutical Chemistry Journal

, Volume 36, Issue 11, pp 631–633 | Cite as

Limit of Quantitation Estimated with Allowance for Reproducibility Requirements

  • N. A. Épshtein
Article

Keywords

Organic Chemistry 
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REFERENCES

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    Validation of Analytical Procedures. Proceedings of the Int. Conf. on Harmonization of Tech. Requirements for the Registration of Pharmaceuticals for Human Use, Geneva (1994).Google Scholar
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    Validation of Analytical Procedures (ICH-Q2A). Proceedings of the Int. Conf. on Harmonization of Tech. Requirements for the Registration of Pharmaceuticals for Human Use, Geneva (1995).Google Scholar
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    Validation of Analytical Procedures: Methodology (ICH-Q2B). Proceedings of the Int. Conf. on Harmonization of Tech. Requirements for the Registration of Pharmaceuticals for Human Use, Geneva (1996).Google Scholar
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    Reviewer Guidance: Validation of Chromatographic Methods, Center for Drug Evaluation and Research, Washington (1994).Google Scholar
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    Validation of Compendial Methods, United States Pharmacopoeia, 24th Ed. (2000), pp. 2149-2152.Google Scholar
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    K. Doerffel, Statistics in Analytical Chemistry [Russian translation], Mir, Moscow (1994).Google Scholar

Copyright information

© Plenum Publishing Corporation 2002

Authors and Affiliations

  • N. A. Épshtein
    • 1
  1. 1.”Akrikhin” Chemico-Pharmaceutical Joint-Stock CompanyStaraya Kupavna, Moscow OblastRussia

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