{"id":22670,"date":"2024-01-23T08:46:04","date_gmt":"2024-01-23T07:46:04","guid":{"rendered":"https:\/\/kymos.com\/news\/perfils-dimpureses-caracteritzacio-dimpureses-desconegudes-en-productes-farmaceutics\/"},"modified":"2024-01-23T08:46:04","modified_gmt":"2024-01-23T07:46:04","slug":"perfils-dimpureses-caracteritzacio-dimpureses-desconegudes-en-productes-farmaceutics","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/perfils-dimpureses-caracteritzacio-dimpureses-desconegudes-en-productes-farmaceutics\/","title":{"rendered":"Perfils d&#8217;impureses: Caracteritzaci\u00f3 d&#8217;impureses desconegudes en productes farmac\u00e8utics"},"content":{"rendered":"<p><span style=\"font-size: 14pt;\">La caracteritzaci\u00f3 de les impureses desconegudes que es troben en subst\u00e0ncies i productes farmac\u00e8utics \u00e9s una part vital del proc\u00e9s d&#8217;aprovaci\u00f3 reglament\u00e0ria. Segons les directrius de l&#8217;ICH, si l&#8217;estimaci\u00f3 indica un contingut d&#8217;impureses superior al 0,1%, s&#8217;ha d&#8217;identificar i caracteritzar garantint el compliment de tots els requisits reglamentaris. Aquest proc\u00e9s tamb\u00e9 es coneix com a <strong>perfil d&#8217;impureses<\/strong> .  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">El present article se centra en aquest proc\u00e9s, donant m\u00e9s context sobre les impureses i detallant quines t\u00e8cniques i equips utilitza Kymos Group per tractar-les.<\/span><\/p>\n<h2><strong>Comprensi\u00f3 de les impureses i la seva classificaci\u00f3<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Segons la definici\u00f3 de l&#8217;OMS, una impuresa \u00e9s &#8220;qualsevol component present en la subst\u00e0ncia o producte farmac\u00e8utic que no \u00e9s el producte desitjat, una subst\u00e0ncia relacionada amb el producte o un excipient, inclosos els components tamp\u00f3. Pot estar relacionada amb el proc\u00e9s o amb el producte&#8221;.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">L&#8217;origen d&#8217;aquestes impureses es pot atribuir a diverses fases del proc\u00e9s sint\u00e8tic del f\u00e0rmac. Es poden trobar als materials de partida, produ\u00efdes en el proc\u00e9s de fabricaci\u00f3, creades en el proc\u00e9s de degradaci\u00f3 format durant l&#8217;emmagatzematge i l&#8217;enviament, o fins i tot als dissolvents utilitzats durant la fabricaci\u00f3. <\/span><\/p>\n<h2><span style=\"font-size: 18pt;\">Classificaci\u00f3 de les impureses en subst\u00e0ncies farmacol\u00f2giques<\/span><\/h2>\n<p><span style=\"font-size: 14pt;\">Combinant la font, la composici\u00f3 i la seguretat biol\u00f2gica, l&#8217;ICH ha elaborat una classificaci\u00f3 important per a les impureses de les subst\u00e0ncies farmacol\u00f2giques:<\/span><\/p>\n<ul>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>Impureses org\u00e0niques:<\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">Es troben durant el proc\u00e9s de fabricaci\u00f3 o es creen durant l&#8217;emmagatzematge. Poden ser identificats o no identificats. Inclouen materials de partida, subproductes, intermediaris, productes de degradaci\u00f3, reactius, lligands i catalitzadors.  <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>Impureses inorg\u00e0niques:  <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">Resultants del proc\u00e9s de fabricaci\u00f3 i normalment coneguts i identificats. S&#8217;hi inclouen reactius, lligands, catalitzadors, <a href=\"https:\/\/kymos.com\/ca\/serveis\/cmc-analisi-i-control-de-qualitat\/elementals-nitrosamines-i-altres-impureses\/impureses-elementals\/\" data-wpel-link=\"internal\">metalls pesants o altres metalls residuals<\/a> , sals inorg\u00e0niques i altres materials com ara coadjuvants de filtraci\u00f3 o carb\u00f3 vegetal. <\/span><\/li>\n<li>\n<h3><span style=\"font-size: 14pt;\"><strong>Dissolvents residuals:  <\/strong><\/span><\/h3>\n<p><span style=\"font-size: 14pt;\">Derivat del proc\u00e9s de fabricaci\u00f3 i classificat en funci\u00f3 del risc potencial per a la salut humana o animal. M\u00e9s informaci\u00f3 sobre <a href=\"https:\/\/kymos.com\/news\/vich-gl18-r2-changes-in-residual-solvents-for-veterinary\/\" data-wpel-link=\"external\">VICH GL18 (R2) i dissolvents residuals.<\/a> <\/span><\/li>\n<\/ul>\n<h2><strong>Directrius sobre el control d&#8217;impureses i la seva caracteritzaci\u00f3<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">Com s&#8217;ha esmentat anteriorment, les directrius de l&#8217;ICH exigeixen que qualsevol impuresa desconeguda present en la nova subst\u00e0ncia farmacol\u00f2gica amb un nivell superior al 0,1% s&#8217;hagi de caracteritzar. Si superen aquest llindar, s&#8217;han d&#8217;identificar i especificar individualment a les especificacions.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Per contra, si una impuresa cau per sota d&#8217;aquest l\u00edmit, la identificaci\u00f3 generalment no \u00e9s necess\u00e0ria, excepte en situacions en qu\u00e8 es preveu que el dany potencial sigui inusualment elevat.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Val a dir que les directrius de l&#8217;ICH exigeixen que els productes de degradaci\u00f3 detectats en els estudis d&#8217;estabilitat del medicament tamb\u00e9 s&#8217;hagin d&#8217;identificar si tenen un nivell superior als llindars d&#8217;identificaci\u00f3. Aquests l\u00edmits es troben a la <a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q3a-r2-impurities-new-drug-substances-scientific-guideline\" data-wpel-link=\"external\">ICH Q3A (R2).<\/a> <\/span><\/p>\n<h2><strong>T\u00e8cniques utilitzades per a la creaci\u00f3 de perfils d&#8217;impureses<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">A l&#8217;hora d&#8217;identificar impureses i productes de degradaci\u00f3, es poden emprar diversos m\u00e8todes. L&#8217;enfocament convencional implica verificar els temps de retenci\u00f3 d&#8217;an\u00e0lits desconeguts en comparaci\u00f3 amb els seus est\u00e0ndards mitjan\u00e7ant un m\u00e8tode desenvolupat, normalment mitjan\u00e7ant l&#8217;addici\u00f3 de compostos.   <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Quan un pic est\u00e0 per sobre del llindar d&#8217;identificaci\u00f3, es marca per a la seva identificaci\u00f3 i elucidaci\u00f3 estructural. A Kymos Group, aquest proc\u00e9s s&#8217;executa habitualment mitjan\u00e7ant <strong>UPLC o HPLC.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Tot i que aquest ha estat el m\u00e8tode convencional durant molts anys, utilitzem predominantment <strong>t\u00e8cniques amb guionet perqu\u00e8 s\u00f3n m\u00e9s r\u00e0pides i f\u00e0cils d&#8217;utilitzar quan s&#8217;han de caracteritzar diverses impureses en una sola mostra.<\/strong> <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Tamb\u00e9 s\u00f3n preferits perqu\u00e8 <strong>evitem possibles problemes quan es formen impureses inestables<\/strong> o si hi ha la possibilitat d&#8217;una reacci\u00f3 secund\u00e0ria durant el processament.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Per aquestes raons espec\u00edfiques, hem decidit utilitzar <strong>LC-MS<\/strong> , ja que t\u00e9 el potencial de proporcionar informaci\u00f3 estructural gaireb\u00e9 clara sobre l&#8217;analit desconegut, i tamb\u00e9 espec\u00edficament sobre l&#8217;espectr\u00f2metre de masses Orbitrap.  <\/span><\/p>\n<h2><strong>Capacitat i noves instal\u00b7lacions del Grup Kymos<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">En resposta al creixement sostingut de les nostres operacions durant el 2023, i espec\u00edficament per satisfer les necessitats dels nostres clients pel que fa a l&#8217;an\u00e0lisi i les proves d&#8217;impureses, recentment hem ampliat les nostres instal\u00b7lacions a It\u00e0lia amb unes instal\u00b7lacions totalment noves.  <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Aquest nou edifici t\u00e9 tres vegades la superf\u00edcie de la planta anterior i compta amb tres nous laboratoris dissenyats amb l&#8217; <a href=\"https:\/\/kymos.com\/ca\/news\/forma-du-i-lean-lab-millora-de-la-productivitat-al-laboratori\/\" data-wpel-link=\"internal\">enfocament &#8220;lean lab&#8221;.<\/a><\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Aquesta inversi\u00f3 estrat\u00e8gica no nom\u00e9s comportar\u00e0 un augment substancial de la nostra capacitat d&#8217;an\u00e0lisi d&#8217;impureses, sin\u00f3 que tamb\u00e9 ampliar\u00e0 la nostra gamma de serveis en recerca, desenvolupament i control de qualitat de productes biofarmac\u00e8utics.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\"><strong>Els nous laboratoris ja han rebut l&#8217;aprovaci\u00f3 de l&#8217;AIFA<\/strong> (Agenzia Italiana del Farmaco) despr\u00e9s d&#8217;una auditoria f\u00edsica exhaustiva de les instal\u00b7lacions, i estem preparats per ajudar en qualsevol projecte que se&#8217;ns presenti.<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">Si necessiteu ajuda amb la caracteritzaci\u00f3 de les impureses o amb qualsevol dels vostres estudis CMC o bioanal\u00edtics, poseu-vos <strong><a href=\"https:\/\/kymos.com\/ca\/contacte\/\" data-wpel-link=\"internal\">en contacte amb nosaltres<\/a><\/strong> o envieu-nos un correu electr\u00f2nic a commercial@kymos.com<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La caracteritzaci\u00f3 de les impureses desconegudes que es troben en  [&#8230;]<\/p>\n","protected":false},"author":7,"featured_media":15861,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[67],"class_list":["post-22670","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca","tag-carles"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Perfils d&#039;impureses: Caracteritzaci\u00f3 d&#039;impureses desconegudes<\/title>\n<meta name=\"description\" content=\"Apr\u00e8n m\u00e9s sobre la caracteritzaci\u00f3 d&#039;impureses en productes farmac\u00e8utics i les t\u00e8cniques utilitzades per tractar-les.\" \/>\n<meta name=\"robots\" content=\"index, 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