Programa para revisão de métodos de identificação por espectroscopia Raman de uma empresa farmacêutica do oeste do Paraná

Abstract

Through the scattered light present in the Raman spectroscopy technique, it is possible to acquire knowledge about the molecular vibrations of the elements, and can provide information about the molecules. Currently Raman spectroscopy has been used in several areas, this is due to the advantages when compared to other techniques, such as speed and being a non-destructive technique. In view of this, the objective of this work was to highlight the applicability of the technique in the pharmaceutical industry. To determine the guidelines that define the entire process of analysis of raw material identification in Raman spectroscopy from the selection of qualified raw materials that will compose the library of specificity and methods, validation tests of the methods with filling of the reports until the procedure necessary for the maintenance and review of these methods to ensure their effectiveness. By means of experimental studies, it was intended to ensure that the method meets the analytical parameters established in Resolution RE nº. 166/17 in chapter 1120 of USP - Raman Spectroscopy, chapter 1225 of the USP - Validation of Compendial Procedures and what the guide ICH Q-2 - Validation of Analytical Procedures: Text and Methodology advocates, thus ensuring the reliability of the results. Based on the results we can attest that the IFA's Dexamethasone Acetate and Nimesulide test was considered approved, since 100% of the readings performed with the three operators present Pass result. For the IFA'S, it was shown that the method needs to undergo a review process, but also a training for employees. Orienting them on how to operate the equipment according to the POP procedure CQ.05.28 concerning. Thus, the methods of execution may present robustness to the materials of Captopril and Terbinafine Hydrochloride.