publication . Article . 2010

Methylprednisolone and its related substances in freeze dried powders for injections

Ljiljana Solomun; Ivan Vuckovic; Svetlana Ibrić; Vlatka Vajs; Zorica Vujić;
Open Access English
  • Published: 01 Oct 2010 Journal: Journal of the Serbian Chemical Society (issn: 0352-5139, Copyright policy)
  • Publisher: Serbian Chemical Society
  • Country: Serbia
In this work, the behavior of the active pharmaceutical substances methylprednisolone (in a form of methylprednisolone sodium succinate) in finished pharmaceutical dosage form, i.e., freeze-dried powder for injections, was examined. The goal was to evaluate the chemical stabilities of methylprednisolone sodium succinate packaged in a dual chamber vial, as a specific container closure system. The effect of different parameters: temperature, moisture and light were monitored. The method proposed by United States Pharmacopeia was used to determine concentrations of methylprednisolone, as the sum of the concentration of methylprednisolone esters (17-hydrogen succina...
free text keywords: methylprednisolone sodium succinate, freeze-dried powder, container closure system, stability, impurities, Chemistry, QD1-999, General Chemistry, Chromatography, Hplc method, Nuclear magnetic resonance spectroscopy, Pharmaceutical Substances, Methylprednisolone, medicine.drug, medicine, Sodium succinate, Dosage form, Impurity
Funded by
The importance of submarine groundwater discharge for the southwestern Baltic Sea
  • Funder: European Commission (EC)
  • Project Code: 293499
  • Funding stream: FP7 | SP3 | PEOPLE
European Marine ScienceMarine Environmental Science: The importance of submarine groundwater discharge for the southwestern Baltic Sea
30 references, page 1 of 2

1. European Pharmacopoeia, 6th ed., European Directorate for the Quality of Medicines, Council of Europe, Strasbourg, 2008, p. 2397

2. British Pharmacopoeia, British Pharmacopoeia Commission, The Stationery Office, London, 2009, p. 1348

3. USP - NF, 32nd ed., United States Pharmacopeia Convention, Inc., Rockville, MD, online version (, 2009 (accessed October, 2010)

4. Japanese Pharmocopoeia, 15th ed., Ministry of Health, Labour and Welfare Ministerial Notification, Society of Japanese Pharmacopoeia, Tokyo, 2006

5. Martindale, The Complete Drug Reference, Thomson Micromedex, Pharmaceutical Press, London, 2005, on-line (, 2009 (accessed October, 2010)

6. S. Gőrőg, Quantitative analysis of Steroids, Elsevier, Amsterdam, 1983, pp. 184-246

7. S. L. Alli, Analytical Profiles of Drug Substances and Excipients, Academic Press, San Diego, CA, 1992, p. 432

8. T. L. Herzog, M. J. Gentles, H. Marshall, E. B. Hershberg, J. Am. Chem. Soc. 83 (1961) 4073

9. M. L. Di Gioia, A. Leggio, A. Le Pera, A. Liguori, A. Napoli, C. Siciliano, G. Sindona, Tetrahedron Lett. 42 (2001) 7413

10. M. L. Lewbart, C. Monder, W. J. Boyko, C. J. Singer, F. Iohan, J. Org. Chem. 54 (1989) 1332

11. G. Ulsaker, G. Teien, Am. J. Health Syst. Pharm. 59 (2002) 2456

12. L. A. Trissel, Y. Zhang, J. Am. Pharm. Assoc. 42 (2002) 868

13. M. I. Amin, J. T. Bryan, J. Pharm. Sci. 62 (1973) 1768

14. J. G. Strom, S. W. Miller, Am. J. Hosp. Pharm. 48 (1991) 1237

15. R. J. Townsend, A. H. Puchala, S. L. Nail, Am. J. Hosp. Pharm. 38 (1981) 1319

30 references, page 1 of 2
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