Pregled bibliografske jedinice broj: 946072
Use of NMR Spectroscopy in Quality Control of Pharmaceutical Products
Use of NMR Spectroscopy in Quality Control of Pharmaceutical Products // AdriaticNMR Book of Abstract / Bregović, Nikola ; Namjesnik, Danijel ; Novak, Predrag ; Pičuljan, Katarina (ur.).
Zagreb: Prirodoslovno-matematički fakultet Sveučilišta u Zagrebu, 2018. str. 32-32 (pozvano predavanje, podatak o recenziji nije dostupan, sažetak, znanstveni)
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Naslov
Use of NMR Spectroscopy in Quality Control of Pharmaceutical Products
Autori
Pitarević, Lovorka
Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni
Izvornik
AdriaticNMR Book of Abstract
/ Bregović, Nikola ; Namjesnik, Danijel ; Novak, Predrag ; Pičuljan, Katarina - Zagreb : Prirodoslovno-matematički fakultet Sveučilišta u Zagrebu, 2018, 32-32
ISBN
978-953-6076-42-0
Skup
Adriatic NMR 2018
Mjesto i datum
Mali Ston, Hrvatska, 15.06.2018. - 17.06.2018
Vrsta sudjelovanja
Pozvano predavanje
Vrsta recenzije
Podatak o recenziji nije dostupan
Ključne riječi
NMR spectroscopy, pharmaceutical product, quality control
(NMR spektroskopija, farmaceutski proizvodi, kontrola kakvoće)
Sažetak
Quality control of finished pharmaceutical product in the shelf-life consists of diverse analytical methods that are validated by manufacturer and approved by national authority. Using system suitability tests the given analytical methods are transferred to the laboratories. Laboratories in charge of monitoring the quality of pharmaceutical products in shelf life are usually a part of national governments in EU, which is also the case in Croatia. Nuclear magnetic resonance spectroscopy is not at all common as a method of choice during quality control of finished pharmaceutical products for identification of active substances or impurities. It is due to different reasons but mainly NMR is not a part of analytical procedures for finished product that are part of the drug master file, DMF. On the other hand, NMR as a method for identification of active substances used in production of the finished product is a main part of DMF. So, in the process of approval of complete drug documentation qualified persons evaluate very complex NMR spectra to be sure that suitable substances are used in the production process. Further on, analysis of counterfeit drugs is a very particular and challenging task, NMR among other analytical methods and techniques found its place in it, especially in the qualitative analytical part.
Izvorni jezik
Engleski
Znanstvena područja
Kemija, Farmacija