Important peculiarities of various technologies used for manufacturing the API of prostate extract that determine different qualitative characteristics of the final product are described. Data on the physicochemical and biological properties of APIs essential for the production of finished dosage forms possessing the desired safety and efficacy indices are presented. The key quality parameters of APIs produced by various technologies are comparatively analyzed.
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 3, pp. 50 – 58, March, 2022.
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Savel’ev, S.A., Dorosh, M.Y., Oparina, T.I. et al. Influence of Manufacturing Technology on the Properties of Active Pharmaceutical Ingredients of Prostate Extract. Pharm Chem J 56, 403–410 (2022). https://doi.org/10.1007/s11094-022-02642-x
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DOI: https://doi.org/10.1007/s11094-022-02642-x