Methylprednisolone and its related substances in freeze-dried powders for injections
Metilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcije
dc.creator | Solomun, Ljiljana | |
dc.creator | Ibrić, Svetlana | |
dc.creator | Vajs, Vlatka | |
dc.creator | Vucković, Ivan M. | |
dc.creator | Vujić, Zorica | |
dc.date.accessioned | 2019-09-02T11:22:21Z | |
dc.date.available | 2019-09-02T11:22:21Z | |
dc.date.issued | 2010 | |
dc.identifier.issn | 0352-5139 | |
dc.identifier.uri | https://farfar.pharmacy.bg.ac.rs/handle/123456789/1426 | |
dc.description.abstract | 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 succinate and 21-hydrogen succinate) and free methylprednisolone. The HPLC method was used for stability evaluation of the active substance and determination of related substances. Four main degradation products were registered. Temperature has a major impact on the degradation process with the appearance of 3 degradation products (impurities B, C and D), while the presence of light caused an increasing content of impurity A. Identification of impurity B, C and D has been realized using mass and NMR spectroscopy. All three substances are substances related to methylprednisolone. | en |
dc.description.abstract | U ovom radu ispitivane su osobine farmakološki aktivne supstance metilprednizolona (u obliku metilprednizolon-natrijum-sukcinata) u gotovom proizvodu - liofilizatu za rastvor za injekcije. Cilj rada je ispitivanje hemijske stabilnosti metilpredni-zolon-natrijum-sukcinata u dvokomornoj bočici, kao specifičnom sistemu kontaktnog pakovanja. Ispitan je efekat različitih parametara: temperature, vlage i svetlosti. Za određivanje koncentracije metilprednizolona, kao zbirne koncentracije metilprednizolon estara (17-hidrogen-sukcinata i 21-hidrogen-sukcinata) i slobodnog metilprednizolona, korišćena je metoda opisana u Američkoj farmakopeji. Za ispitivanje srodnih supstanci primenjena je HPLC metoda. Uočena su 4 degradaciona proizvoda. Dokazano je da povećanje temperature ima najveći značaj na proces degradacije i utiče na povećanje sadržaja nečistoća B, C i D, dok prisustvo svetlosti dovodi do povećanja sadržaja nečistoće A. Nečistoće B, C i D su identifikovane primenom masene i NMR spektroskopije. Sve tri nečistoće su identifikovane kao srodne supstance metilprednizolona. | sr |
dc.publisher | Srpsko hemijsko društvo, Beograd | |
dc.relation | info:eu-repo/grantAgreement/MESTD/MPN2006-2010/142072/RS// | |
dc.rights | openAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | |
dc.source | Journal of the Serbian Chemical Society | |
dc.subject | methylprednisolone sodium succinate | en |
dc.subject | freeze-dried powder | en |
dc.subject | container closure system | en |
dc.subject | stability | en |
dc.subject | impurities | en |
dc.title | Methylprednisolone and its related substances in freeze-dried powders for injections | en |
dc.title | Metilprednizolon i njegove srodne supstance u liofilizatu za rastvor za injekcije | sr |
dc.type | article | |
dc.rights.license | BY-NC-ND | |
dcterms.abstract | Соломун, Љиљана; Вајс, Влатка; Вуцковић, Иван М.; Ибрић, Светлана; Вујић, Зорица; Метилпреднизолон и његове сродне супстанце у лиофилизату за раствор за ињекције; Метилпреднизолон и његове сродне супстанце у лиофилизату за раствор за ињекције; | |
dc.citation.volume | 75 | |
dc.citation.issue | 10 | |
dc.citation.spage | 1441 | |
dc.citation.epage | 1452 | |
dc.citation.other | 75(10): 1441-1452 | |
dc.citation.rank | M23 | |
dc.identifier.wos | 000283895200013 | |
dc.identifier.doi | 10.2298/JSC100115087S | |
dc.identifier.scopus | 2-s2.0-78449271200 | |
dc.identifier.fulltext | https://farfar.pharmacy.bg.ac.rs//bitstream/id/326/1424.pdf | |
dc.type.version | publishedVersion |