Aspectos históricos e técnicos da aplicação das técnicas de espectrometria atômica na análise de impurezas inorgânicas elementares em insumos e produtos da indústria farmacêutica

Abstract

The presence of some organic impurities and elementaries in inputs, excipients and exemples pharmaceuticals in the global pharmaceutical industry, with these should be monitored and blind. Previously, a North American Pharmacopoeia (USP), bringing the chapter on Heavy Metals, colorimetric methods also known as "boundary test of metals", which was based on the sequence of 10 chemical elements. or an analysis by Atomic Absorption Spectroscopy by Graphite Furnace (Atomic Absorption Graphite Furnace, GFAAS), which allows obtaining quantitative results. In 2008, an International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products for Human Use was formed, which, together with USP, proposed a modernization for the instrumentation methods for testing elemental impurities, proceeding from the 41st edition Elemental Impurities - Limits (Elementary Impurities - Limits) and <233> Element Impurities - Element Impurities - Inductively Coupled Plasma Optical Emission Spectrometry (Inductively Coupled Plasma Optical Emission Spectrometry, ICP-OES) and Mass Spectrometry inductively coupled plasma (inductively coupled plasma coupled mass spectrometry, ICP-MS). Key to the analyze multi-detecting analytics multi-elementary detectors with major frequency testing (mg/L up to ng/L). The present work has the objective of establishing historical and technical aspects of qualitative and quantitative analyzes applied in the pharmaceutical industry in the control of elemental impurities.