We present a comparative analysis of the methods for quality evaluation and standardization of the parent substance of fentanyl based on foreign pharmacopoeias and domestic regulations. Harmonization of the tests and norms is proposed for the sections identification, determination of foreign impurities, and quantification. The harmonization is carried out at the stage of monograph preparation for the revised version of existing regulations.
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U. A. Murashova, N. P. Sadchikova, L. V. Skalkina, and S. K. Smirnov, Khim.-farm. Zh., 38(6), 48–50 (2004).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 42, No. 9, pp. 54–56, September, 2008.
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Murashova, U.A., Skalkina, L.V., Sadchikova, N.P. et al. Harmonization of quality indicators of the domestic parent substance fentanyl. Pharm Chem J 42, 550–552 (2008). https://doi.org/10.1007/s11094-009-0166-6
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DOI: https://doi.org/10.1007/s11094-009-0166-6