LUNA SAUCEDO, Bárbara; FERNANDEZ RUIZ, Rosabel    QUEVEDO ALVAREZ, Odalys. ELEMENTAL IMPURITIES IN NATURAL ACTIVE INGREDIENTS. RISK-BASED APPROACH ACCORDING TO ICH AND USP. []. , 54, pp. 109-121.   01--2023. ISSN 2221-2442.

On a global scale, regulatory authorities are responsible for ensuring that pharmaceutical products, including those of natural origin, are effective and safe. Likewise, they require the control of elemental impurities (EI), which are more toxic to man, classified by the ICH and the USP as class I (Cd, Pb, As and Hg). They raise the need for a Risk Assessment, taking into account the toxicity of the impurity, the probability of finding it in the product and the permissible daily exposure limit (PDE), according to the route of administration (µg/day). The purpose of this work is to apply risk assessment of elemental impurities, according to USP and ICH, to natural active ingredients (AI) produced at the CNIC. The appropriate daily concentration limits for each impurity in the AIs were calculated from the established EDPs, taking into account the maximum daily dose. When comparing the detection limits of the procedures implemented with the values established for Cd, Pb, As and Hg, it can be seen that they are lower than the latter, and that it is possible to reliably quantify these EI by Atomic Absorption Spectrometry. The identification and evaluation of risks showed that the risk associated with the presence of elemental impurities is low, which shows the effectiveness of the control implemented. The risk-based approach, combined with the knowledge and control of the potential sources of IE in the production of AI, will allow maintaining an efficient control strategy for these impurities in CNIC.

: inorganic elemental impurities; regulatory authorities; risk.

        · |     · |     · ( pdf )