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Determination of Organic Impurities in Combination Drugs

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

Methodological approaches to the control of organic impurities in drugs containing two and more active pharmaceutical ingredients are reviewed. Approaches of leading foreign pharmacopoeias (British, USA, Japanese) to assessing impurity profiles in combination drugs are analyzed. The methods for assessing impurities that carry the largest safety risks for combination drugs are determined. It is demonstrated that a unified approach to the control of organic impurities in combination drugs is needed.

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation, Moscow, 127051, Russia

    O. A. Matveeva & E. L. Kovaleva

Authors
  1. O. A. Matveeva
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  2. E. L. Kovaleva
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Correspondence to O. A. Matveeva.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 51, No. 2, pp. 30 – 33, February, 2017.

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Matveeva, O.A., Kovaleva, E.L. Determination of Organic Impurities in Combination Drugs. Pharm Chem J 51, 126–129 (2017). https://doi.org/10.1007/s11094-017-1570-y

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  • DOI: https://doi.org/10.1007/s11094-017-1570-y

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