Pharmaceutical post-marketing analytical development

diplomski rad

• Autor: Dijana Vitko
• Mentor: Ivone Jakaša (mentor)
• Ustanova koja je dodijelila akademski / stručni stupanj: Sveučilište u Zagrebu; Prehrambeno-biotehnološki fakultet; Zagreb
• Datum i država obrane: 2010-07-02, Hrvatska
• Znanstveno / umjetničko područje, polje i grana: BIOTEHNIČKE ZNANOSTI; Biotehnologija

Sažetak

During nineteen weeks of my internship in Technologie SERVIER I have had an opportunity to work with experts in the field of analytical chemistry and take up basic analytical methods used in pharmaceutical development. In my report I have described methods I have used in control batch analyses of Almitrine bismesylate salt and Indapamide spiked reference batch: High Performance Liquid Chromatography (HPLC) and Infrared Spectroscopy for drug substance identification Thin Layer Chromatography (TLC) for the purity verification Karl Fischer titration for the water content determination. After accomplishing my first objective to become self-confident and independent in using analytical instruments on my own, I was given a responsibility to test British pharmacopoeia draft for the Perindopril Monograph template. Therefore I was challenged to verify reproducibility of proposed Perindopril identification test and Perindopril tablet dissolution test suitability using infrared spectroscopy and HPLC-UV, respectively. Furthermore, rather than just point out British pharmacopoeia draft monograph’s ambiguities I also tried to give possible effective solutions to improve currently proposed methods.

• Ključne riječi: analytical development; control analyses; pharmaceuticals; pharmacopoeia; post-marketing.
• Jezik: engleski
• URN:NBN: urn:nbn:hr:159:073937
• Studijski program: Naziv: Molekularna biotehnologija; Vrsta studija: sveučilišni; Stupanj studija: diplomski; Akademski / stručni naziv: magistar/magistra inženjer/inženjerka molekularne biotehnologije (mag. ing. biotechn.)
• Vrsta resursa: Tekst
• Način izrade datoteke: Izvorno digitalna
• Prava pristupa: Pristup korisnicima matične ustanove
• Datum i vrijeme pohrane: 2017-06-02 11:36:07