<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2221-2442</journal-id>
<journal-title><![CDATA[Revista CENIC Ciencias Químicas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. CENIC Cienc. Quím.]]></abbrev-journal-title>
<issn>2221-2442</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Investigaciones Científicas]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2221-24422023000100109</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[IMPUREZAS ELEMENTALES EN INGREDIENTES ACTIVOS NATURALES. ENFOQUE BASADO EN EL RIESGO CONFORME A ICH Y USP]]></article-title>
<article-title xml:lang="en"><![CDATA[ELEMENTAL IMPURITIES IN NATURAL ACTIVE INGREDIENTS. RISK-BASED APPROACH ACCORDING TO ICH AND USP]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Luna Saucedo]]></surname>
<given-names><![CDATA[Bárbara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández Ruiz]]></surname>
<given-names><![CDATA[Rosabel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Quevedo Alvarez]]></surname>
<given-names><![CDATA[Odalys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Investigaciones Científicas (CNIC)  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro Nacional de Investigaciones del Petróleo (CEINPET)  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<volume>54</volume>
<fpage>109</fpage>
<lpage>121</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2221-24422023000100109&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2221-24422023000100109&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2221-24422023000100109&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN A escala mundial, las autoridades reguladoras son las responsables de garantizar que los productos farmacéuticos, incluyendo los de origen natural, sean eficaces y seguros. Asimismo, exigen el control de las impurezas elementales (IE) más tóxicas para el hombre, clasificadas por la ICH y la USP como clase I (Cd, Pb, As y Hg). Plantean la necesidad de una Evaluación de Riesgos, teniendo en cuenta la toxicidad de la impureza, la probabilidad de encontrarla en el producto y el límite de exposición diaria permisible de (EDP), según la vía de administración (µg/día). Este trabajo tuvo como objetivo aplicar la evaluación de riesgos de impurezas elementales, conforme a USP e ICH, a ingredientes activos (IA) naturales producidos en el CNIC. Se calcularon los límites de concentración diaria apropiada para cada impureza en los IA, a partir de los EDP establecidos, teniendo en cuenta la dosis diaria máxima. Al comparar los límites de detección de los procedimientos implementados con los límites de concentración elemental calculados, se aprecia que son inferiores a estos últimos y que es posible la cuantificación de estas IE de manera confiable por Espectrometría de Absorción Atómica. La identificación y evaluación de riesgos demostró que el riesgo asociado a la presencia de impurezas elementales es bajo, lo cual evidencia la eficacia de los controles implementados. El enfoque basado en el riesgo, combinado con el conocimiento y control de las fuentes potenciales de IE en la producción de IA, permitirá mantener una estrategia de control eficiente para estas impurezas en el CNIC.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT 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.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[impurezas elementales inorgánicas]]></kwd>
<kwd lng="es"><![CDATA[autoridades reguladoras]]></kwd>
<kwd lng="es"><![CDATA[riesgos]]></kwd>
<kwd lng="en"><![CDATA[inorganic elemental impurities]]></kwd>
<kwd lng="en"><![CDATA[regulatory authorities]]></kwd>
<kwd lng="en"><![CDATA[risk]]></kwd>
</kwd-group>
</article-meta>
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