Português

Abstract

The use of natural products raw materials for compounding pharmacies has been growing, as consumers are looking for a great variety and quality of herbal products. To obtain these characteristics in the compounding medicines, it is necessary to evaluate the information present in the certificates of analysis of the manufacturers/suppliers of the natural products, since the lack of information hinders the quality control tests carried out in the compounding pharmacy. To propose an improvement in the information provided in the certificates of analysis of natural products, this study conducted a retrospective descriptive study, using twenty certificates of analysis of natural products most acquired by a compounding pharmacy, located in the city of Rio de Janeiro. The certificates were compared with the quality requirements determined by the Resolution– RDC n° 14/2013 and RDC n° 67/2007. There was a great variation of the information in the reports, in addition to the lack of standardization of the botanical nomenclature, absence of a precise description of the organoleptic characteristics, extracting liquids, methods of identification of the active ingredient, and solubility. About 70% of the certificates used the manufacturer's methodology as a reference. Thus, it was evidenced that it is necessary a standardization between the standards required by the National Health Surveillance Agency (ANVISA) and the manufacturers/suppliers, which are of great importance for the compounding pharmacy to perform, with reproducibility, quality control tests of the natural raw products, ensuring the quality and safety of the drug that will be produced.