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- W2186200830 abstract "The aim of this study was to determine the applicability of IR spectrometry in the study of drug-related impurities, method which is usually applied as an identification method. We intended to determine the extent to which an impurity of the drug-substance can be detected by IR spectra interpretation and by other possibilities offered by the software used for data processing. Also by choosing proper impurities, impurity A for simvastatin and impurity H for atorvastatin, we aimed to develop a rapid method suitable for stability studies. In order to determine the limit of an impurity detectable by FTIR, mixtures with different concentrations of the drug substance and impurity were analyzed. Confirmation of the exact concentration of the impurity in samples was carried out by high performance liquid chromatography with UV detection. Rezumat Lucrarea de faţa si-a propus sa determine aplicabilitatea spectrometriei IR in studiul impuritaţilor inrudite chimic, metoda care in prezent este aplicata in laboratoare in specialca metoda de identificare. Ne-am propus sa determinam limita la care o impuritate poate fi detectata din substanţa, prin interpretarea spectrelor si prin aplicarea posibilitaţilor oferite de programul informatic utilizat. Totodata, prin alegerea corecta a impuritaţilor, impuritatea A in cazul simvastatinei si impuritatea H in cazul atorvastatinei, s-a urmarit dezvoltarea unei metode potrivite pentru studii de stabilitate ale acestor substanţe. Pentru determinarea limitei la care o impuritate poate fi detectata, s-au analizat probe marcate cu impuritaţi in diferite concentraţii. Confirmarea concentraţiilor probelor in impuritaţi s-a realizat prin analiza HPLC cu detecţie in UV." @default.
- W2186200830 created "2016-06-24" @default.
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- W2186200830 date "2013-01-01" @default.
- W2186200830 modified "2023-09-24" @default.
- W2186200830 title "ANALYSIS OF DRUG RELATED IMPURITIES BY INFRARED SPECTROMETRY IN THE CLASS OF STATINS" @default.
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