The applicability of solid state characterization and analytical techniques for reference chemical substance certification: Resolution of the Collegiate Board (RDC) 166/2017 by National Health Surveillance Agency (ANVISA)

Abstract

Reference chemical substances called primary reference are used which are marketed by official compendia both nationally and internationally in the pharmaceutical industry as a tool for identification and quantification during pre-formulation, development/analytical validation and quality control studies. The reference or primary standards are almost always imported and resold in the Brazilian market as a consequence, increasing the cost in relation to the sample amount (little amount of mass in mg per bottle). On July 24, 2017, the National Health Surveillance Agency (ANVISA) published the Resolution of the Collegiate Board (RDC) number 166, which deals with the validation of analytical methods. The Chapter III of this resolution is intended for reference chemical substances and, in Art. 14 § 1, the RDC 166/2017 allows the use of characterized reference chemical substances in the analytical validations. The characterization study is planned according to the chemical structure of the substance to be characterized and within this new regulation, solid-state characterization and analytical chemistry stands out as an essential ally corroborating with the evolution of the number of publications in the literature regarding this subject in the google scholar database as shown in Figures 1 and 2.