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

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Pharmaceutical Chemistry Journal Aims and scope

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.

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References

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  2. Ministry of Health and Social Development of the RF Order No. 756n dated Aug. 26, 2010 (amended Jun. 1, 2017, No. 615n) “On approval of the procedure for developing general pharmacopoeial monographs and pharmacopoeial monographs and including them in the State Pharmacopoeia and placing them on the official internet site for State Pharmacopoeia data,” Reg. Min. Just. Russia, Aug. 31, 2010, No. 18298, Moscow (2010).

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  9. United States Pharmacopeia, USP 40-NF 35 (2017); http://www.uspnf.com/uspnf/display?cmd=jsp&page=chooser

  10. Japanese Pharmacopoeia, 17th Ed., PMDA (2016); http://jpdb.nihs.go.jp/jp17e/

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  13. British Pharmacopoeia, BP 2017 (2017); https://www.pharmacopoeia.com/

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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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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051, Russia

    Yu. V. Olefir, E. I. Sakanyan, A. I. Luttseva, L. G. Babeshina & T. B. Shemeryankina

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  1. Yu. V. Olefir
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  2. E. I. Sakanyan
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  3. A. I. Luttseva
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  4. L. G. Babeshina
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  5. T. B. Shemeryankina
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Corresponding author

Correspondence to E. I. Sakanyan.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 52, No. 10, pp. 59 – 64, October, 2018.

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Olefir, Y.V., Sakanyan, E.I., Luttseva, A.I. et al. Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program. Pharm Chem J 52, 873–877 (2019). https://doi.org/10.1007/s11094-019-1919-5

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  • DOI: https://doi.org/10.1007/s11094-019-1919-5

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