{"id":22694,"date":"2022-07-25T15:08:34","date_gmt":"2022-07-25T13:08:34","guid":{"rendered":"https:\/\/kymos.com\/news\/impureses-elementals-noves-regulacions-per-a-productes-farmaceutics-i-cosmetics-dus-huma-i-veterinari\/"},"modified":"2022-07-25T15:08:34","modified_gmt":"2022-07-25T13:08:34","slug":"impureses-elementals-noves-regulacions-per-a-productes-farmaceutics-i-cosmetics-dus-huma-i-veterinari","status":"publish","type":"post","link":"https:\/\/kymos.com\/ca\/news\/impureses-elementals-noves-regulacions-per-a-productes-farmaceutics-i-cosmetics-dus-huma-i-veterinari\/","title":{"rendered":"Impureses elementals: Noves regulacions per a productes farmac\u00e8utics i cosm\u00e8tics d’\u00fas hum\u00e0 i veterinari"},"content":{"rendered":"

Les impureses elementals en productes farmac\u00e8utics, per\u00f2 tamb\u00e9 cosm\u00e8tics, reben cada cop m\u00e9s l’atenci\u00f3 de les autoritats. Constantment es defineixen nous l\u00edmits i \u00e9s essencial estar sempre al dia de les darreres normatives. Gemma Solsona, cap del departament d’impureses elementals, informa sobre les novetats normatives recents m\u00e9s importants: <\/span><\/p>\n

“Actualment, s’estan produint diversos canvis alhora. En primer lloc, la Guia per a productes farmac\u00e8utics d’\u00fas hum\u00e0: impureses elementals ICH Q3D (R2) ara inclou la via cut\u00e0nia i transcut\u00e0nia<\/strong> , juntament amb les vies oral, parenteral i inhalat\u00f2ria. Anteriorment, quan la nova versi\u00f3 encara no estava disponible, aplic\u00e0vem els l\u00edmits menys restrictius (els de la via oral) per a la determinaci\u00f3 d’impureses elementals per a productes farmac\u00e8utics aplicats per via cut\u00e0nia i transcut\u00e0nia. Amb els nous l\u00edmits establerts per a la via cut\u00e0nia i transcut\u00e0nia disponibles, ara podem veure que els nostres clients estaven segurs per a tots els elements, excepte per al Ni<\/strong> i el Co.<\/strong> Aquests elements es consideren sensibilitzadors i els nous l\u00edmits s\u00f3n inferiors als que s’apliquen per a l’administraci\u00f3 oral. Per tant, la nostra recomanaci\u00f3 \u00e9s revaluar tots dos elements per assegurar-nos que els resultats siguin perfectes per a la seva presentaci\u00f3 a les autoritats.” <\/span><\/p><\/blockquote>\n\n\n\n
En el seu departament ben equipat, l’equip de Gemma Solsona pot determinar els 24 elements enumerats a la guia ICH Q3D en una prova de cribratge est\u00e0ndard i fins a 10 elements addicionals sota petici\u00f3 espec\u00edfica. Utilitzen instruments d’espectrometria de masses amb plasma acoblat a ions (ICP-MS), que permeten l\u00edmits de detecci\u00f3 m\u00e9s baixos i cribratge multielemental simultani. <\/span><\/p>\n

A m\u00e9s, l’equip de Kymos t\u00e9 una llarga experi\u00e8ncia en la quantificaci\u00f3 d’elements en mostres biol\u00f2giques, tant per determinar nivells t\u00f2xics de metalls pesants com per a estudis farmacocin\u00e8tics de metal\u00b7lf\u00e0rmacs per a usos terap\u00e8utics, com ara Sr, Li, Pt, Fe, Gd, etc. <\/span><\/td>\n

\"impureses<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u00abNo obstant aix\u00f2, els canvis en la guia ICH Q3D per a les impureses elementals no s\u00f3n el final de la hist\u00f2ria\u00bb, continua la Gemma amb el seu resum dels canvis normatius. \u00abUn altre requisit nou \u00e9s que, abans del gener del 2023… s’ha de dur a terme una an\u00e0lisi de riscos completa per a les impureses elementals en tots els medicaments veterinaris per demostrar el compliment de la Monografia General 2619 de la Farmacologia Europea. <\/strong>. Aquest \u00e9s un repte important per a les empreses veterin\u00e0ries, ja que no han hagut de tractar amb impureses elementals abans. Nosaltres podem ajudar aqu\u00ed. Kymos t\u00e9 molts anys d’experi\u00e8ncia no nom\u00e9s en el camp de les impureses elementals, sin\u00f3 tamb\u00e9 amb productes veterinaris. En conjunt, aix\u00f2 ens fa perfectes per a la feina. Estarem encantats de proporcionar una consulta inicial. Els clients poden contactar-me directament a gsolsona@kymos.com<\/a> . <\/span><\/p><\/blockquote>\n

Finalment, des del 2022 no nom\u00e9s les empreses farmac\u00e8utiques han de prestar atenci\u00f3 a les impureses elementals. La norma ISO 23192:2021 ara especifica un m\u00e8tode anal\u00edtic mitjan\u00e7ant el qual les empreses cosm\u00e8tiques han de sotmetre els seus productes a proves de metalls pesants<\/strong> . Aquest m\u00e8tode est\u00e0 predesenvolupat a l’equip de la Gemma i es pot utilitzar en qualsevol moment. Gemma Solsona ho resumeix: <\/span><\/p>\n

“Ja sigui hum\u00e0, farmac\u00e8utic veterinari o cosm\u00e8tic. Tenim l’experi\u00e8ncia, l’equip i els coneixements necessaris per determinar les impureses elementals. Vine i deixa’ns ajudar-te. Esperem amb il\u00b7lusi\u00f3 molts projectes nous i emocionants sobre impureses elementals.” <\/span><\/p><\/blockquote>\n

Descobreix m\u00e9s sobre els serveis d’impureses elementals de Kymos a la nostra p\u00e0gina web d’impureses elementals.<\/a><\/span><\/p>\n

O coneix els nostres experts al FarmaForum<\/span><\/a> de Madrid, del 5 al 6 d’octubre de 2022, i assisteix al taller de Kymos: “Tend\u00e8ncies recents en el perfil d’impureses dels productes farmac\u00e8utics”<\/strong> . Apr\u00e8n m\u00e9s no nom\u00e9s sobre les impureses elementals, sin\u00f3 tamb\u00e9 sobre les nitrosamines i els materials extra\u00efbles i lixiviables. Registra’t<\/a><\/span> ara! <\/span><\/h2>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Les impureses elementals en productes farmac\u00e8utics, per\u00f2 tamb\u00e9 cosm\u00e8tics, reben […]<\/p>\n","protected":false},"author":7,"featured_media":15272,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[97],"tags":[67],"class_list":["post-22694","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc-ca","tag-carles"],"acf":[],"yoast_head":"\nImpureses elementals Noves regulacions - Kymos<\/title>\n<meta name=\"description\" content=\"Gemma Solsona, cap de departament d'Impureses Elementals, informa sobre les noves regulacions per a productes farmac\u00e8utics i cosm\u00e8tics humans i veterinaris\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kymos.com\/ca\/news\/impureses-elementals-noves-regulacions-per-a-productes-farmaceutics-i-cosmetics-dus-huma-i-veterinari\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Impureses elementals Noves regulacions - 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