<?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>S2221-24422022000200252</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[ESTUDIOS DE ESTABILIDAD DEL D005, NUEVO INGREDIENTE FARMACÉUTICO ACTIVO OBTENIDO A PARTIR DE LOS FRUTOS DE ACROCOMIA CRISPA]]></article-title>
<article-title xml:lang="en"><![CDATA[STABILITY STUDIES OF D005, NEW ACTIVE PHARMACEUTICAL INGREDIENT OBTAINED FROM THE FRUITS OF ACROCOMIA CRISPA]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sierra Pérez]]></surname>
<given-names><![CDATA[Roxana de la Caridad]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González Canavaciolo]]></surname>
<given-names><![CDATA[Víctor Luis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vicente Murillo]]></surname>
<given-names><![CDATA[Roxana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Tamame Tirado]]></surname>
<given-names><![CDATA[Dayana]]></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>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2022</year>
</pub-date>
<volume>53</volume>
<numero>2</numero>
<fpage>252</fpage>
<lpage>259</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2221-24422022000200252&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2221-24422022000200252&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2221-24422022000200252&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN Los fitofármacos no solo requieren procesos de producción reproducibles y controles de calidad eficientes sino también estudios de estabilidad que garanticen su eficacia y seguridad durante todo su período de vida útil. D005 es un nuevo ingrediente activo antioxidante y antiinflamatorio con beneficios sobre el daño pulmonar agudo y el daño renal, que está compuesto principalmente por ácidos grasos libres, extraídos y purificados del aceite de los frutos de la palma corojo (Acrocomia crispa), especie cubana endémica de la familia Arecaceae. Teniendo en cuenta el uso potencial de este ingrediente activo, fue necesario determinar su estabilidad. Para ello, muestras de D005 envasado en frascos de vidrio ámbar y vidrio transparente fueron sometidas a condiciones de estrés (oxidación, fotólisis y termólisis), y muestras de D005 envasado en frascos de vidrio ámbar fueron almacenadas en condiciones aceleradas (40°C y 75% HR) durante 12 meses y en condiciones de refrigeración (6 ºC y 60 % de HR) y zona climática IV (30°C y 70% HR) durante 36 meses. Los parámetros de calidad del D005: pérdida por secado, densidad relativa, índice de refracción e índice de acidez, cumplieron con los requerimientos de la industria farmacéutica y la concentración de ácidos grasos se encontró dentro del intervalo establecido. Sus principales vías de degradación fueron la fotólisis y la termólisis, y se mantuvo estable durante 12 meses en condiciones de estabilidad acelerada y durante 36 meses en condiciones de refrigeración y de la zona climática IV, siendo el frasco de vidrio ámbar el que mayor protección le ofreció.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT Phytopharmaceuticals not only require reproducible production processes and efficient quality controls, but also stability studies that guarantee their efficacy and safety throughout their shelf life. D005 is a new antioxidant and anti-inflammatory active ingredient with benefits on acute lung damage and kidney damage, which is mainly composed of free fatty acids, extracted and purified from the oil of the fruits of the corojo palm (Acrocomia crispa), an endemic Cuban species of the Arecaceae family. Taking into account the potential use of this active ingredient, it was necessary to determine its stability. For this, samples of D005 packaged in amber glass and transparent glass bottles were subjected to stress conditions (oxidation, photolysis and thermolysis), and samples of D005 packaged in amber glass bottles were stored under accelerated conditions (40°C and 75 % RH) for 12 months and under refrigeration conditions (6ºC and 60% RH) and climate zone IV conditions (30°C and 70% RH) for 36 months. The quality parameters of D005: loss on drying, relative density, refractive index, and acid index, fulfilled the requirements of the pharmaceutical industry and the concentration of fatty acids was within the established range. Its main degradation pathways were photolysis and thermolysis, and its remains stable for 12 months under accelerated stability conditions and for 36 months under refrigeration and climatic zone IV conditions, being the glass bottle the one that offered the greatest protection.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[D005]]></kwd>
<kwd lng="es"><![CDATA[estabilidad]]></kwd>
<kwd lng="es"><![CDATA[estrés]]></kwd>
<kwd lng="es"><![CDATA[acelerado]]></kwd>
<kwd lng="es"><![CDATA[a largo plazo]]></kwd>
<kwd lng="en"><![CDATA[D005]]></kwd>
<kwd lng="en"><![CDATA[stability]]></kwd>
<kwd lng="en"><![CDATA[stress]]></kwd>
<kwd lng="en"><![CDATA[accelerated]]></kwd>
<kwd lng="en"><![CDATA[long term]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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