Pharmaceutical Chemistry Journal

, Volume 42, Issue 9, pp 550–552 | Cite as

Harmonization of quality indicators of the domestic parent substance fentanyl

  • U. A. Murashova
  • L. V. Skalkina
  • N. P. Sadchikova
  • S. K. Smirnov
Structure of Chemical Compounds, Methods of Analysis and Process Control

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.


Fentanyl Parent Substance Ammonium Carbonate Fentanyl Citrate Monobasic Potassium Phosphate 
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Copyright information

© Springer Science+Business Media, Inc. 2008

Authors and Affiliations

  • U. A. Murashova
    • 1
  • L. V. Skalkina
    • 1
  • N. P. Sadchikova
    • 2
  • S. K. Smirnov
    • 1
  1. 1.Federal Scientific CenterState Institute of Organic Chemistry and TechnologyMoscowRussia
  2. 2.Sechenov Medical AcademyMoscowRussia

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