{"id":22682,"date":"2023-07-20T15:24:04","date_gmt":"2023-07-20T13:24:04","guid":{"rendered":"https:\/\/kymos.com\/news\/proves-de-dietilenglicol-deg-i-etilenglicol-eg-en-components-de-farmacs-dalt-risc\/"},"modified":"2023-07-20T15:24:04","modified_gmt":"2023-07-20T13:24:04","slug":"proves-de-dietilenglicol-deg-i-etilenglicol-eg-en-components-de-farmacs-dalt-risc","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/proves-de-dietilenglicol-deg-i-etilenglicol-eg-en-components-de-farmacs-dalt-risc\/","title":{"rendered":"Proves de dietilenglicol (DEG) i etilenglicol (EG) en components de f\u00e0rmacs d&#8217;alt risc"},"content":{"rendered":"<p>Arran de diversos incidents globals relacionats amb productes farmac\u00e8utics contaminats dissenyats espec\u00edficament per a nens, la Food and Drug Administration (FDA) dels Estats Units va publicar un document d&#8217;orientaci\u00f3 per abordar el <strong>perill potencial de la contaminaci\u00f3 per dietilenglicol (DEG) i etilenglicol (EG) en diferents components farmac\u00e8utics<\/strong> . Aquests incidents es van produir en set pa\u00efsos entre el 2022 i el 2023 i han plantejat la necessitat d&#8217;avaluar aquesta situaci\u00f3. <\/p>\n<p>La guia de la FDA substitueix el seu darrer document del 2007 i alerta la ind\u00fastria que, a m\u00e9s de la glicerina, hi ha altres components amb un alt risc de contaminaci\u00f3 amb DEG i EG, com ara el propilenglicol (PEG), la soluci\u00f3 de maltitol, l&#8217;hidrolitzat de mid\u00f3 hidrogenat i la soluci\u00f3 de sorbitol.<\/p>\n<h2><strong>Experi\u00e8ncia de Kymos en l&#8217;an\u00e0lisi de glicerina i propilenglicol<\/strong><\/h2>\n<p>A Kymos, tenim una \u00e0mplia experi\u00e8ncia en l&#8217;an\u00e0lisi <strong>de contaminants DEG i EG en glicerina i propilenglicol.<\/strong> Aquestes an\u00e0lisis les realitzen equips d&#8217;experts utilitzant t\u00e8cniques est\u00e0ndard de la ind\u00fastria com ara la cromatografia de gasos amb detecci\u00f3 d&#8217;ionitzaci\u00f3 de flama (GC\/FID) o la cromatografia l\u00edquida d&#8217;alt rendiment amb detecci\u00f3 d&#8217;\u00edndex de refracci\u00f3 (HPLC\/RID). Els nostres m\u00e8todes anal\u00edtics s&#8217;alineen amb els requisits descrits a les monografies de la USP, la Farmacopea Europea i la Farmacopea Japonesa, aix\u00ed com amb els m\u00e8todes interns dels clients. <\/p>\n<h3><strong>Implementaci\u00f3 de proves de contaminants per a altres excipients<\/strong><\/h3>\n<p>Tot i que actualment ens hem centrat en la glicerina i el PEG, Kymos Group est\u00e0 ben preparat per implementar i validar m\u00e8todes de prova per <strong>determinar aquests contaminants en altres components del medicament segons calgui<\/strong> . Les directrius de la FDA subratllen la import\u00e0ncia de prevenir l&#8217;\u00fas d&#8217;altres components potencialment contaminats, com ara <em>la soluci\u00f3 de maltitol, l&#8217;hidrolitzat de mid\u00f3 hidrogenat<\/em> i <em>la soluci\u00f3 de sorbitol.<\/em> <\/p>\n<p>Com a laboratori d&#8217;an\u00e0lisis, Kymos Group ent\u00e9n la import\u00e0ncia d&#8217;adaptar-se als requisits en constant evoluci\u00f3 de la ind\u00fastria i ampliar\u00e0 f\u00e0cilment les seves capacitats d&#8217;an\u00e0lisi per incloure excipients addicionals segons calgui.<\/p>\n<h3><strong>Garantir el compliment normatiu i prevenir les intoxicacions dels consumidors<\/strong><\/h3>\n<p>El compliment dels requisits reglamentaris \u00e9s crucial per als fabricants de productes farmac\u00e8utics, els reenvasadors, els prove\u00efdors de components de medicaments d&#8217;alt risc i els fabricants de compostos. Kymos Group reconeix la import\u00e0ncia d&#8217;aquests requisits per prevenir les intoxicacions dels consumidors i es compromet a donar suport als seus clients i socis en el compliment de les bones pr\u00e0ctiques de fabricaci\u00f3 actuals (CGMP). <\/p>\n<p>Aprofitant la nostra experi\u00e8ncia en proves anal\u00edtiques i garantia de qualitat, podem ajudar a prevenir incidents de contaminaci\u00f3 i els danys posteriors als pacients.<\/p>\n<h3>Conclusions sobre el dietilenglicol i l&#8217;etilenglicol com a contaminants (contaminaci\u00f3 per DEG i EG)<\/h3>\n<p>Les recents directrius de la FDA sobre les proves de components de f\u00e0rmacs d&#8217;alt risc per a la contaminaci\u00f3 per DEG i EG han impulsat la necessitat d&#8217;una major vigil\u00e0ncia entre la ind\u00fastria. Kymos Group, com a CRO anal\u00edtica, posseeix l&#8217;experi\u00e8ncia, l&#8217;equipament i les metodologies necess\u00e0ries per ajudar els fabricants de productes farmac\u00e8utics, les instal\u00b7lacions externalitzades i les farm\u00e0cies de preparaci\u00f3 a complir aquests requisits de prova. <\/p>\n<p>Amb una traject\u00f2ria demostrada en l&#8217;an\u00e0lisi de glicerina i PEG, Kymos Group est\u00e0 ben equipat per ampliar les seves capacitats per abastar altres components de f\u00e0rmacs d&#8217;alt risc, quan sigui necessari. Treballant junts, podem garantir la seguretat i la integritat dels productes farmac\u00e8utics i protegir la salut dels pacients a tot el m\u00f3n. <\/p>\n<p>Si necessiteu ajuda amb algun dels vostres projectes, poseu-vos <a href=\"https:\/\/kymos.com\/ca\/contacte\/\" data-wpel-link=\"internal\">en contacte amb nosaltres<\/a> .<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Arran de diversos incidents globals relacionats amb productes farmac\u00e8utics contaminats  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":15312,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97,106],"tags":[67],"class_list":["post-22682","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca","category-novetats","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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la FDA sobre la contaminaci\u00f3 per DEG i EG i sobre com Kymos Group us pot ajudar a garantir la seguretat i el compliment normatiu.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kymos.com\/ca\/news\/proves-de-dietilenglicol-deg-i-etilenglicol-eg-en-components-de-farmacs-dalt-risc\/\" \/>\n<meta property=\"og:site_name\" content=\"Kymos\" \/>\n<meta property=\"article:published_time\" content=\"2023-07-20T13:24:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kymos.com\/wp-content\/uploads\/2023\/07\/DEGEG-Testing-Image.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1398\" \/>\n\t<meta property=\"og:image:height\" content=\"724\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Carles Celma\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@KymosGroup\" \/>\n<meta name=\"twitter:site\" content=\"@KymosGroup\" \/>\n<meta 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