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Dissolution Test: Causes of Understated Results and their Elimination (Review)

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

Understated results of the pharmacopoeial Dissolution test are often encountered in practice. Elimination of this problem is not an easy task. This review considers possible causes of obtaining underestimated data during the development, validation, and use of drug Dissolution test methods. Four groups of factors that can potentially lead to understates results of the Dissolution test are discussed in detail, including (1) factors related to the analytical method, dissolution tester performance, and data collection; (2) factors associated with the dissolution medium; (3) factors related to the properties of the drug substance; and (4) technological factors. Recommendations for eliminating understated results of the Dissolution test are given.

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

    N. A. Epshtein

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  1. N. A. Epshtein
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Correspondence to N. A. Epshtein.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 8, pp. 55 – 59, August, 2021.

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Epshtein, N.A. Dissolution Test: Causes of Understated Results and their Elimination (Review). Pharm Chem J 55, 821–825 (2021). https://doi.org/10.1007/s11094-021-02501-1

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  • DOI: https://doi.org/10.1007/s11094-021-02501-1

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