{"id":28093,"date":"2023-07-20T15:24:04","date_gmt":"2023-07-20T13:24:04","guid":{"rendered":"https:\/\/kymos.com\/news\/tests-de-diethylene-glycol-deg-et-dethylene-glycol-eg-sur-les-composants-de-medicaments-a-haut-risque\/"},"modified":"2023-07-20T15:24:04","modified_gmt":"2023-07-20T13:24:04","slug":"tests-de-diethylene-glycol-deg-et-dethylene-glycol-eg-sur-les-composants-de-medicaments-a-haut-risque","status":"publish","type":"post","link":"https:\/\/kymos.com\/fr\/news\/tests-de-diethylene-glycol-deg-et-dethylene-glycol-eg-sur-les-composants-de-medicaments-a-haut-risque\/","title":{"rendered":"Tests de di\u00e9thyl\u00e8ne glycol (DEG) et d’\u00e9thyl\u00e8ne glycol (EG) sur les composants de m\u00e9dicaments \u00e0 haut risque"},"content":{"rendered":"

Suite \u00e0 plusieurs incidents internationaux impliquant des m\u00e9dicaments contamin\u00e9s destin\u00e9s sp\u00e9cifiquement aux enfants, la FDA (Food and Drug Administration) am\u00e9ricaine a publi\u00e9 un document d’orientation relatif aux risques potentiels de contamination par le di\u00e9thyl\u00e8ne glycol (DEG) et l’\u00e9thyl\u00e8ne glycol (EG) dans diff\u00e9rents composants pharmaceutiques<\/strong> . Ces incidents, survenus dans sept pays entre 2022 et 2023, ont mis en \u00e9vidence la n\u00e9cessit\u00e9 d’\u00e9valuer cette situation. <\/p>\n

Les recommandations de la FDA remplacent son dernier document de 2007 et alertent l’industrie sur le fait qu’en plus de la glyc\u00e9rine, d’autres composants pr\u00e9sentent un risque \u00e9lev\u00e9 de contamination par le DEG et l’EG, notamment le propyl\u00e8ne glycol (PEG), la solution de maltitol, l’hydrolysat d’amidon hydrog\u00e9n\u00e9 et la solution de sorbitol.<\/p>\n

L’expertise de Kymos en mati\u00e8re d’analyse de la glyc\u00e9rine et du propyl\u00e8ne glycol<\/strong><\/h2>\n

Chez Kymos, nous poss\u00e9dons une vaste exp\u00e9rience dans l’analyse des contaminants DEG et EG dans la glyc\u00e9rine et le propyl\u00e8ne glycol.<\/strong> Ces analyses sont r\u00e9alis\u00e9es par des \u00e9quipes d’experts utilisant des techniques standard telles que la chromatographie en phase gazeuse avec d\u00e9tection par ionisation de flamme (GC\/FID) ou la chromatographie liquide \u00e0 haute performance avec d\u00e9tection par indice de r\u00e9fraction (HPLC\/RID). Nos m\u00e9thodes analytiques sont conformes aux exigences des monographies de l’USP, de la Pharmacop\u00e9e europ\u00e9enne et de la Pharmacop\u00e9e japonaise, ainsi qu’aux m\u00e9thodes internes de nos clients. <\/p>\n

Mise en \u0153uvre de tests de contaminants pour d’autres excipients<\/strong><\/h3>\n

Bien que nos efforts se concentrent actuellement sur la glyc\u00e9rine et le PEG, le groupe Kymos est parfaitement pr\u00e9par\u00e9 \u00e0 mettre en \u0153uvre et \u00e0 valider des m\u00e9thodes de test pour d\u00e9tecter ces contaminants dans d’autres composants de m\u00e9dicaments, le cas \u00e9ch\u00e9ant<\/strong> . Les recommandations de la FDA soulignent l’importance de pr\u00e9venir l’utilisation d’autres composants potentiellement contamin\u00e9s, tels que la solution de maltitol, l’hydrolysat d’amidon hydrog\u00e9n\u00e9<\/em> et la solution de sorbitol.<\/em> <\/p>\n

En tant que laboratoire d’analyse, le groupe Kymos comprend l’importance de s’adapter \u00e0 l’\u00e9volution des exigences de l’industrie et \u00e9tendra volontiers ses capacit\u00e9s d’analyse pour inclure des excipients suppl\u00e9mentaires selon les besoins.<\/p>\n

Garantir la conformit\u00e9 et pr\u00e9venir les intoxications des consommateurs<\/strong><\/h3>\n

Le respect des exigences r\u00e9glementaires est essentiel pour les fabricants de produits pharmaceutiques, les reconditionneurs, les fournisseurs de composants pharmaceutiques \u00e0 haut risque et les pr\u00e9parateurs. Le groupe Kymos reconna\u00eet l’importance de ces exigences pour pr\u00e9venir les intoxications chez les consommateurs et s’engage \u00e0 accompagner ses clients et partenaires dans le respect des bonnes pratiques de fabrication (BPF) en vigueur. <\/p>\n

En tirant parti de notre expertise en mati\u00e8re d’analyses et d’assurance qualit\u00e9, nous pouvons contribuer \u00e0 la pr\u00e9vention des incidents de contamination et des dommages qui en d\u00e9coulent pour les patients.<\/p>\n

Conclusions sur le di\u00e9thyl\u00e8ne glycol et l’\u00e9thyl\u00e8ne glycol en tant que contaminants (contamination par le DEG et l’EG)<\/h3>\n

Les r\u00e9centes recommandations de la FDA concernant le d\u00e9pistage de la contamination par le DEG et l’EG dans les composants pharmaceutiques \u00e0 haut risque ont incit\u00e9 l’industrie \u00e0 redoubler de vigilance. En tant qu’organisme de recherche sous contrat (CRO) sp\u00e9cialis\u00e9 en analyses, Kymos Group poss\u00e8de l’expertise, les \u00e9quipements et les m\u00e9thodologies n\u00e9cessaires pour accompagner les fabricants de produits pharmaceutiques, les sous-traitants et les pharmacies de pr\u00e9paration magistrale dans le respect de ces exigences. <\/p>\n

Fort d’une solide exp\u00e9rience dans l’analyse de la glyc\u00e9rine et du PEG, le groupe Kymos est parfaitement outill\u00e9 pour \u00e9tendre ses comp\u00e9tences \u00e0 d’autres composants pharmaceutiques \u00e0 haut risque, selon les besoins. En collaborant, nous pouvons garantir la s\u00e9curit\u00e9 et l’int\u00e9grit\u00e9 des m\u00e9dicaments et prot\u00e9ger la sant\u00e9 des patients du monde entier. <\/p>\n

Si vous avez besoin d’aide pour l’un de vos projets, n’h\u00e9sitez pas \u00e0 nous contacter<\/a> .<\/p>\n","protected":false},"excerpt":{"rendered":"

Suite \u00e0 plusieurs incidents internationaux impliquant des m\u00e9dicaments contamin\u00e9s destin\u00e9s […]<\/p>\n","protected":false},"author":7,"featured_media":28098,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[267,258],"tags":[67],"class_list":["post-28093","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cmc","category-nouvelles","tag-carles"],"acf":[],"yoast_head":"\nContamination par le DEG et l'EG des composants m\u00e9dicamenteux \u00e0 haut risque<\/title>\n<meta name=\"description\" content=\"Pour en savoir plus, consultez la nouvelle alerte et les directives de la FDA concernant la contamination par le DEG et l'EG, et d\u00e9couvrez comment Kymos Group peut vous aider \u00e0 garantir la s\u00e9curit\u00e9 et la conformit\u00e9.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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