Controle de qualidade na indústria farmacêutica: contribuição para a identificação de substâncias química caracterizadas por ressonância magnética nuclear de 1H e 13C

Abstract

The need for safe and reliable quality control of finished products and / or raw materials is of utmost importance to the pharmaceutical industry as well as to the users of these products, ensuring the quality, safety and efficacy of the medicines. In order to evaluate the quantification and / or identification of pharmaceutical products, it is necessary to compare with a known standard of purity and identity, with official reference standards (valid compendial) being recommended, and in the absence of these, duly characterized reference standards. For the characterization of a standard it is necessary to guarantee identity, content, quality, purity and potency. In this context, nuclear magnetic resonance technique is one of the main methods for obtaining detailed information on chemical structures and helps confirm and establish the identity of the pharmaceutical substances and impurities. Thus, in this work the 1H and 13C NMR technique was used to interpret spectra obtained by a third party laboratory for acebrophylline, cannabidiol, deferasirox and ketotifen fumarate, contributing with the knowledge to identify the chemical substances used in the control quality and evaluation of services provided by outsourced laboratories.