Study of the thermogravimetric analysis application to determine volatile impurities for the reference standards certification

Authors

  • Дмитрий Анатольевич Леонтьев Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085, Ukraine https://orcid.org/0000-0003-1129-8749
  • Наталья Валерьевна Воловик Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085, Ukraine https://orcid.org/0000-0002-9660-8162
  • Елена Валерьевна Бевз Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085, Ukraine https://orcid.org/0000-0002-7695-3612
  • Ольга Валерьевна Ващенко Instіtute for Scintillation Materials of NAS of Ukraine Nauki ave., 60, Kharkiv, Ukraine, 61001, Ukraine https://orcid.org/0000-0002-7447-9080
  • Лилия Владимировна Будянская Instіtute for Scintillation Materials of NAS of Ukraine Nauki ave., 60, Kharkiv, Ukraine, 61001, Ukraine https://orcid.org/0000-0003-4967-1035

DOI:

https://doi.org/10.15587/2519-4852.2016.74460

Keywords:

reference standards, certification, volatile impurities, thermogravimetric analysis, measurement uncertainty

Abstract

Aim. To study thermal gravimetric analysis (TGA) application for the reference standards certification, considering the uncertainty metrological concept of the State Pharmacopoeia of Ukraine.

Methods. Thermogravimetric analysis, mathematical statistics methods.

Results. TGA application to determine volatile impurities for the reference standards certification was studied, considering the requirements for making the reliable conclusion about quality of medicines (95 %). Requirements to the volatile impurities content uncertainty were formulated. It has been found, that measurement uncertainty evaluation for the volatile impurities determination, using TGA method, meets the strictest requirements for the pharmaceutical reference standards certification.

Conclusion. It has been shown, that TGA method allows the use of minimum weighed portions, typical for pharmaceutical analysis practice: 10 mg for quantitative determination, 5 mg or less for purity tests, 10 mg for homogeneity tests, which is the strictest requirement for pharmaceutical reference standards

Author Biographies

Дмитрий Анатольевич Леонтьев, Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085

Candidate of Pharmaceutical Sciences, Senior Research Fellow, Deputy Director (on Science), Head of the Department

Department of Validation and Reference Standards

Наталья Валерьевна Воловик, Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085

Candidate of Pharmaceutical Sciences, Deputy Head of a Department

Department of Validation and Reference Standards

Елена Валерьевна Бевз, Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Astronomichna str., 33, Kharkiv, Ukraine, 61085

Junior Research Fellow

Department of Validation and Reference Standards

Ольга Валерьевна Ващенко, Instіtute for Scintillation Materials of NAS of Ukraine Nauki ave., 60, Kharkiv, Ukraine, 61001

Candidate of Physical and Mathematical Sciences, Senior Research Fellow

References

  1. Nogueira, R., Queiroz, S. M., Silva, G. E. B., Rocha, W. F. C., Sarmanho, G. F., Almeida, R. R. R., Moreira, G. F. (2012). Determination of volatiles in pharmaceutical certified reference materials. Journal of the Brazilian Chemical Society, 23 (9), 1636–1646. doi: 10.1590/s0103-50532012005000021
  2. Derzhavna Farmakopeja Ukrai'ny. Vol. 1 (2015). Kharkiv: Derzhavne pidpryjemstvo «Ukrai'ns'kyj naukovyj farmakopejnyj centr jakosti likars'kyh zasobiv», 1128.
  3. ISO Guide 34:2009(E): General requirements for the competence of reference material producers (2009). Geneva: International Organization for Standardization. ISO copyright office, 34.
  4. Leontiev, D. A.; V. P. Georgievskii (Ed.) (2012). Farmacevticheskie standartnye obrazcy. Analiticheskaya himiya v sozdanii, standartizacii i kontrole kachestva lekarstvennyh sredstv. Kharkiv: NTMT, 1064–1118.
  5. ICH Harmonised Tripartite Guideline: Quality Risk Management (Q 9). Current Step 4 version. (2005). The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 19.
  6. Leontiev, D. A., Volovyk, N. V., Gryzodoub, A. I. (2015). Sistema farmakopejnyh standartnyh obrazcov Gosudarstvennoj Farmakopei Ukrainy: koncepciya sozdaniya i tekushchee sostoyanie. Farmacevticheskij zhurnal (Kazakhstan), 2, 29–37.
  7. ISO Guide 35:2006: Reference materials – general and statistical principles for certification (2006). Geneva: International Organization for Standardization. ISO copyright office, 65.
  8. The United States Pharmacopoeia. USP 39–NF 34. Rockville: The United States Pharmacopeial Convention. Available at: http://www.uspnf.com
  9. European Pharmacopoeia (2015). Strasbourg: European Department for the Quality of Medicines.
  10. Leontiev, D. A., Gryzodoub, A. I., Levin, M. G., Docenko, T. N. (2002). Attestaciya farmacevticheskih standartnyh obrazcov: izuchenie odnorodnosti. Farmakom, 3, 104–116.
  11. Leontiev, D. A. (2016) Stvorennya sistemi farmacevtichnih standartnih zrazkіv v Ukrai'nі. Kharkiv, 42.
  12. Doehrfel', K. (1994). Statistika v analiticheskoj himii. Мoscow: Mir, 268.

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Published

2016-08-31

How to Cite

Леонтьев, Д. А., Воловик, Н. В., Бевз, Е. В., Ващенко, О. В., & Будянская, Л. В. (2016). Study of the thermogravimetric analysis application to determine volatile impurities for the reference standards certification. ScienceRise: Pharmaceutical Science, (2 (2), 10–15. https://doi.org/10.15587/2519-4852.2016.74460

Issue

No. 2 (2) (2016)

Section

Pharmaceutical Science

License

Copyright (c) 2016 Дмитрий Анатольевич Леонтьев, Наталья Валерьевна Воловик, Елена Валерьевна Бевз, Ольга Валерьевна Ващенко, Лилия Владимировна Будянская

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