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Pharmaceutical Chemistry Journal

, Volume 53, Issue 5, pp 477–482 | Cite as

Correction Factors in Formulas for Calculating Impurity Contents: Essence and Determination Methods and Their Limitations

  • N. A. ÉpshteinEmail author
Article
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Formulas for calculating relative response factors (RRFs) and correction factors (Fs) of impurities and those necessary for understanding the essence of RRFs and Fs are presented. The main methods for determining Fs and their limitations (conditions necessary for correct determination of RRFs and Fs) are considered. These limitations do not appear in the European and US pharmacopoeias although they must be considered to determine the correct Fs. Examples and recommendations are given for reliable determination and correct use of the Fs.

Keywords

correction factor response factor relative response factor impurities recommendations 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Center for Registration and Development of Medicines, LLC IRVIN 2MoscowRussia

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