Análisis de impurezas elementales en productos farmacéuticos por ICP-OES


Fernández Nobau, Jordi


Despite the great technological development that has been experienced during the last decades, the analysis of metallic impurities in pharmaceutical products has not followed the same line. During recent times the official method of analysis was the precipitation of heavy metal sulphides and a colorimetric analysis. This method had two disadvantages. The first is that not all heavy metals are able to form sulphides, and the second is their lack of selectivity. Due to these factors, the application of this method made the correct quantification of the total metallic impurities impossible and did not allow the determination of the toxicity of the product because not all heavy metals have the same toxicity.
In order to take care of those issues, at the end of 2014 , ICH established that it will be necessary to provide more detailed information for all the commercialized pharmaceutical products about their heavy metal content in accordance with the changes in the Pharmacopoeias (EP and USP), according to ICH Q3D.
EP and USP propose two methods based on spectrometry: ICP-OES and ICP-MS. In the present work, the development of a method using ICP-OES that meets the criteria established by the Pharmacopoeias and that can be implemented in the Laboratory of Metal Analysis of the Institut Químic de Sarrià is studied. Linearity and stability of the elements collected in the ICH-Q3D are studied using ICP-OES and a validation method with a sample of ascorbic acid is proposed, starting with a 0.25g/50mL sample preparation and with a linear range of 4-40 mg / kg-1, evaluating the criteria established in the Pharmacopoeias.



Verdaguer Ferrer, Ariadna
Blanco Roca, Pepa


IQS SE - Master’s Degree in Analytical Chemistry