Avaliação da conformidade de álcool etílico antisséptico e higienizante durante a flexibilização de comercialização pela anvisa

Abstract

Quality control is a very important step in the production of sanitizers, since these formulations reduce the contamination and transmission statistics of pathogens. With the outbreak of COVID-19, alcohol-based antiseptics became the best and most common alternative to conventional hand cleaning in healthcare, commercial and domestic activities as a prevention tool, causing an increase in the demand for alcohol , ANVISA as a national health regulatory agency, took an emergency action to face the growing demand for alcohol and proposed through RDC No. 422 of September 16, 2020 the possibility of manufacturing and marketing ethanol-based sanitizers for small companies without prior authorization from the regulatory agency, as a result of the flexibilization action and also due to the demand for quality control of sanitizers, fast, ecological and low-cost analytical methods become very necessary to determine the concentration of ethanol in marketed products . The most important step performed during the quality control of ethanolic formulations is the quantification of the ethanol content which, according to ANVISA, should not vary by more than 10% of the ethanol content in order to achieve its objective and for cosmetics indicated for services of health, except in liquid form, must respect the minimum content of 68.25%. Given the above, this study aimed to determine the alcohol content of 20 commercial samples of sanitizing alcohol in order to compare the levels found with those reported on the labels, indicating which samples were within the variation limit established by ANVISA. Twenty different commercial samples were acquired in supermarkets and pharmacies in the cities of João Pessoa and Remígio (PB), in July and September 2021. The alcohols were named AG (1-10) for the gel and AL samples (1-10) ) for liquid samples, hiding the brands and manufacturers. The samples were subjected to analysis using refractometry, pycnometry and alcohol analysis to determine the ethanol content, and discussions and comparisons were applied to these techniques.