Pour renforcer la s\u00e9curit\u00e9 des patients, l\u2019European Pharmacop\u00e9e (Eur. Ph.) propose une nouvelle m\u00e9thode d\u2019analyse destin\u00e9e \u00e0 rep\u00e9rer et contr\u00f4ler deux impuret\u00e9s potentiellement toxiques : l\u2019\u00e9thyl\u00e8ne glycol (EG) et le di\u00e9thyl\u00e8ne glycol (DEG) dans les excipients pharmaceutiques. Cette proposition figure dans la monographie r\u00e9vis\u00e9e Macrogols (1444), qui concerne 12 types de macrogol (ou poly\u00e9thyl\u00e8ne glycol). Cette mise \u00e0 jour a \u00e9t\u00e9 publi\u00e9e dans le num\u00e9ro 38.3 de Pharmeuropa.<\/p>\n
La m\u00e9thode propos\u00e9e repose sur une technique de chromatographie en phase gazeuse utilisant une colonne capillaire. Elle permet de mesurer avec pr\u00e9cision les taux d\u2019impuret\u00e9s apr\u00e8s une \u00e9tape de d\u00e9rivation chimique et gr\u00e2ce \u00e0 l\u2019ajout d\u2019un standard interne. La monographie Macrogols (1444) sugg\u00e8re \u00e9galement de nouvelles limites maximales pour l\u2019EG et le DEG : 620 parties par million (ppm) pour l\u2019\u00e9thyl\u00e8ne glycol et 0,10 % pour le di\u00e9thyl\u00e8ne glycol. \u00c0 titre de comparaison, la version actuelle de la monographie fixe une limite globale pour les deux substances.<\/p>\n
Les professionnels sont invit\u00e9s \u00e0 partager leurs donn\u00e9es analytiques, qu\u2019elles aient \u00e9t\u00e9 obtenues avec la m\u00e9thode propos\u00e9e ou une autre technique, afin de valider ces nouvelles limites. Leurs retours permettront de s\u2019assurer que ces seuils sont adapt\u00e9s et efficaces.<\/p>\n
Par ailleurs, l\u2019European Pharmacop\u00e9e a r\u00e9cemment adopt\u00e9 des monographies mises \u00e0 jour pour le propyl\u00e8ne glycol (0430) et la glyc\u00e9rine (0496), renfor\u00e7ant ainsi le contr\u00f4le de la contamination par l\u2019EG et le DEG dans les excipients. D\u2019autres tests d\u00e9di\u00e9s \u00e0 ces impuret\u00e9s sont pr\u00e9vus pour le sorbitol et le maltitol liquides.<\/p>\n
Les professionnels ont jusqu\u2019au 30 septembre pour soumettre leurs commentaires sur la monographie Macrogols (1444). Des instructions pour fournir un retour d\u2019information sont disponibles en ligne.<\/p>\n
En parall\u00e8le, l\u2019European Pharmacop\u00e9e a r\u00e9cemment actualis\u00e9 le chapitre g\u00e9n\u00e9ral 5.1.6 concernant les m\u00e9thodes microbiologiques alternatives. Cette r\u00e9vision vise \u00e0 moderniser les approches de contr\u00f4le qualit\u00e9 en supprimant les m\u00e9thodes d\u00e9pass\u00e9es. Elle r\u00e9pond \u00e0 la demande croissante pour des proc\u00e9d\u00e9s plus rapides, y compris ceux int\u00e9grant des technologies innovantes comme l\u2019intelligence artificielle. Cette nouvelle version du chapitre entrera en vigueur le 1er avril prochain.<\/p>\n","protected":false},"excerpt":{"rendered":"
Pour renforcer la s\u00e9curit\u00e9 des patients, l\u2019European Pharmacop\u00e9e (Eur. Ph.) propose une nouvelle m\u00e9thode d\u2019analyse destin\u00e9e \u00e0 rep\u00e9rer et contr\u00f4ler […]<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[414],"tags":[],"class_list":["post-429","post","type-post","status-publish","format-standard","hentry","category-nouvelles"],"_links":{"self":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/429","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/comments?post=429"}],"version-history":[{"count":1,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/429\/revisions"}],"predecessor-version":[{"id":438,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/429\/revisions\/438"}],"wp:attachment":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/media?parent=429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/categories?post=429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/tags?post=429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}