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Pharmacopoeial Quality Requirements for Medicinal Products

  • Yu. V. Olefir
  • E. I. SakanyanEmail author
  • L. I. Shishova
  • S. P. Senchenko
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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General approaches to the elaboration of pharmacopoeial quality standards for medicinal products that are based on good pharmacopoeial practice (GPhP) rules of domestic and leading foreign pharmacopoeias are presented.

Keywords

medicinal products pharmacopoeial requirements pharmacopoeial monograph dosage forms 

Notes

Acknowledgments

The work was sponsored by State Task for SCEEMP, Ministry of Health of Russia, No. 056-00023-18-02 for applied scientific research (State Account No. NIR AAAA-A18-118021590049-0).

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • Yu. V. Olefir
    • 1
  • E. I. Sakanyan
    • 1
    Email author
  • L. I. Shishova
    • 1
  • S. P. Senchenko
    • 1
  1. 1.Scientific Center for Expert Evaluation of Medicinal ProductsMinistry of Health of the Russian FederationMoscowRussia

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