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undergraduate thesis
Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama
Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology, 2017. urn:nbn:hr:149:520398
Sindičić, Valnea
University of Zagreb
Faculty of Chemical Engineering and Technology

Institutional repository: Repository of Faculty of Chemical Engineering and Technology University of Zagreb

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Sindičić, V. (2017). Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama (Undergraduate thesis). Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology. Retrieved from https://urn.nsk.hr/urn:nbn:hr:149:520398

Sindičić, Valnea. "Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama." Undergraduate thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2017. https://urn.nsk.hr/urn:nbn:hr:149:520398

Sindičić, Valnea. "Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama." Undergraduate thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, 2017. https://urn.nsk.hr/urn:nbn:hr:149:520398

Sindičić, V. (2017). 'Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama', Undergraduate thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, accessed 18 November 2024, https://urn.nsk.hr/urn:nbn:hr:149:520398

Sindičić V. Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama [Undergraduate thesis]. Zagreb: University of Zagreb, Faculty of Chemical Engineering and Technology; 2017 [cited 2024 November 18] Available at: https://urn.nsk.hr/urn:nbn:hr:149:520398

V. Sindičić, "Primjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama", Undergraduate thesis, University of Zagreb, Faculty of Chemical Engineering and Technology, Zagreb, 2017. Available at: https://urn.nsk.hr/urn:nbn:hr:149:520398

Metadata
TitlePrimjena metode ubrzanog stabilitetnog testiranja na aktivnim farmaceutskim supstancama
Title (english)Application of accelerated stability testing method on pharmaceutical active substances
AuthorValnea Sindičić
MentorŠime Ukić (mentor)
Committee memberŠime Ukić (predsjednik povjerenstva)
Committee memberDanijela Ašperger (član povjerenstva)
Committee memberMarijana Kraljić Roković (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Chemical Engineering and Technology
Zagreb
Defense date and country2017-09-18, Croatia
Scientific / art field,
discipline and subdiscipline		NATURAL SCIENCES
Chemistry
Analytic Chemistry
Abstract
Ovaj rad izrađen je u PLIVA d.o.o., Hrvatska te zbog poslovne tajnosti nije moguće iznositi točna imena uzoraka i aktivnih farmaceutskih supstanci kao ni njihove karakteristike. Tijekom razvoja aktivnih farmaceutskih supstanci (API-ja) potrebno je provesti nekoliko dugoročnih stabilitetnih testiranja. Rok trajanja, koji se treba odrediti, temelji se na vremenu u kojem API ostaje unutar svojih granica specifikacije tijekom nastanka produkata razgradnje. Osiguravanje stabilnog proizvoda od iznimne je važnosti za zdravlje bolesnika. Primjena programa ubrzane procjene stabilnosti (ASAP) omogućuje predviđanje roka trajanja API-ja u svega dva tjedna koristeći kontrolirane komore za stabilnost u minijaturi i statističke protokole. ASAP se znanstveno bazira na korigiranoj Arrheniusovoj jednadžbi koja se koristi za procjenu učinaka temperature i vlage na stupanj degradacije API-ja. U ovom radu primijenjena je ova kratkotrajna metoda ispitivanja na dvokomponentnom API-ju za testiranje međusobnih utjecaja kemijske stabilnosti. Produkti degradacije određeni su pomoću UHPLC-a s DAD detektorom i C18 separacijskom kolonom. Razvijena je kromatografska metoda za odvajanje svih produkata razgradnje i dva API-ja. Rezultati su pokazali aditivni učinak u stabilnosti dvokomponentnog sustava u dvotjednom razdoblju testiranja.
Abstract (english)
This bachelor thesis was made in PLIVA d.o.o., Croatia and due to the company confidentiality policy it's not possible to disclose exact names of samples and active pharmaceutical ingredients as well as theirs characteristics. During the development of an active pharmaceutical ingredients (APIs), certain number of the long-term stability testings are required. Shelf-life, which has to be determined, is based on the period in which API stays within the limits of it's specification during the formation of the degradation products. Ensuring the stability of product is of exceptional importance for patients' health. The application of The Accelerated Stability Assessment Program (ASAP) enables APIs shelf-life prediction in just two weeks by using controlled miniature stability chambers and the statistical protocols. ASAP is scientifically based on corrected Arrhenius equation which is used for estimation of the effects of temperature and humidity on the degradation rate of APIs. In this thesis, explained short-term testing method was applied on a two-component API for testing of mutual effects in chemical stability. Degradation products were determined by UHPLC with a DAD detector and C18 separation column. Chromatographic method was developed for separation of all degradation products and two APIs. Results have shown additive effect in stability of two-component system during the two-week testing period.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:149:520398
Study programmeTitle: Applied Chemistry - Undergraduate study; specializations in: Environmental chemistry and green technologies, Advanced materials and technologies, Applied organic chemistry
Course: Applied organic chemistry
Study programme type: university
Study level: undergraduate
Academic / professional title: sveučilišni/a prvostupnik/prvostupnica (baccalaureus/baccalaurea) primijenjene kemije (sveučilišni/a prvostupnik/prvostupnica (baccalaureus/baccalaurea) primijenjene kemije)
Type of resourceText
File originBorn digital
Access conditionsOpen access
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Created on2021-03-12 12:37:35