Abstract
Based on a comparative analysis of various approaches to and requirements on standardization and evaluation of the quality of substances in European and United States Pharmacopoeias and various national normative documents, a project of the general pharmacopoeia article “Pharmaceutical Substances” has been prepared. This article establishes the general requirements on the active and auxiliary components used in the production of ready-to-use preparations.
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References
State Pharmacopoeia of Ukraine [in Ukrainian], Kiev (2001).
European Pharmacopoeia (4th Ed.), Strasbourg (2002).
United States Pharmacopoeia (29th Ed.), Washington (2005).
British Pharmacopoeia, London (2004).
Industrial Standard OST 42-1-71 “Order of Development, Agreement, and Approval of Normative and Technical Documents for Medicinals and Medicinal Plant Materials.”
Industrial Standard OST 42-506-96 “Order of Development, Agreement, and Approval of Normative and Technical Documents for Medicinals and Medicinal Plant Materials.”
Industrial Standard OST 91500.05.001-00 “Quality Standards for Medicinals. General Stipulations.”
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 41, No. 1, pp. 35–37, January, 2007.
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Bagirova, V.L., Kovaleva, E.L. & Shanazarov, K.S. Preparing a pharmacopoeial article on pharmaceutical substances. Pharm Chem J 41, 34–36 (2007). https://doi.org/10.1007/s11094-007-0008-3
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DOI: https://doi.org/10.1007/s11094-007-0008-3