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Pharmaceutical Chemistry Journal

, Volume 52, Issue 10, pp 873–877 | Cite as

Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program

  • Yu. V. Olefir
  • E. I. SakanyanEmail author
  • A. I. Luttseva
  • L. G. Babeshina
  • T. B. Shemeryankina
Article
  • 36 Downloads

Experimental validation of methods and procedures featured in draft general pharmacopoeial and pharmacopoeial monographs is an important task for Russian compendial science and practice. These studies provide a basis for adopting state compendial drug quality standards. They enable both manufacturers and quality-control organizations to perform independent quality control of drug substances and medicinal preparations that helps to protect public health.

Keywords

validation testing verification State Pharmacopoeia pharmacopoeial monograph compendial standards drugs drug substances medicinal preparations 

Notes

Acknowledgments

The work was performed in the framework of SCEEMP, MH, RF, State Task 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
  • A. I. Luttseva
    • 1
  • L. G. Babeshina
    • 1
  • T. B. Shemeryankina
    • 1
  1. 1.Scientific Center for Expert Evaluation of Medicinal ProductsMinistry of Health of the Russian FederationMoscowRussia

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