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Validation of Related-Substances Determination Methods for Detecting Unidentified Substances (A Review)

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

The review justifies the need to validate the linearity, relative accuracy, and precision of Related Substances methods for detecting unidentified substances. Various approaches and methods for the estimation of linearity, precision, relative accuracy, and other validation characteristics for unidentified impurities are considered. The conditions necessary for the correct application of these approaches are discussed. The term “main unidentified impurities” is proposed and justified for assessing the validation results. Acceptance criteria, examples, and recommendations are provided.

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Notes

  1. If unidentified impurities are ignored during validation of RSB procedures then even stress tests are not always conducted [12, 13] although, as a rule, the specificity of an RSB procedure cannot be correctly evaluated without them.

  2. Acceptance criteria are numerical limits, ranges, or other criteria used to accept test results.

  3. Information on the required columns for USP procedures: http://www.usp.org/resources/chromatographic-columns; for European compendial procedures, in Knowledge Database: https:/extranet.edqm.eu/publications/recherches sw.shtml.

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Authors and Affiliations

  1. Department of Registration and Development of Medicines, IRVIN 2 LLC, 13A Kolomenskii Proezd, Moscow, 115446, Russia

    N. A. Epshtein

  2. STADA PharmDevelopment Autonomous Corp., NIZHFARM LLC, 2B/9 Otradnaya St, Moscow, 127273, Russia

    V. L. Sevast’yanova & A. I. Koroleva

Authors
  1. N. A. Epshtein
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  2. V. L. Sevast’yanova
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  3. A. I. Koroleva
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Correspondence to N. A. Epshtein.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 9, pp. 48 – 56, September, 2020.

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Epshtein, N.A., Sevast’yanova, V.L. & Koroleva, A.I. Validation of Related-Substances Determination Methods for Detecting Unidentified Substances (A Review). Pharm Chem J 54, 959–967 (2020). https://doi.org/10.1007/s11094-020-02303-x

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  • DOI: https://doi.org/10.1007/s11094-020-02303-x

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