{"id":28844,"date":"2025-02-26T11:45:18","date_gmt":"2025-02-26T10:45:18","guid":{"rendered":"https:\/\/minakem.com\/?page_id=28844"},"modified":"2025-12-29T10:46:55","modified_gmt":"2025-12-29T09:46:55","slug":"sciences-analytiques","status":"publish","type":"page","link":"https:\/\/minakem.com\/fr\/sciences-analytiques\/","title":{"rendered":"Sciences analytiques"},"content":{"rendered":"

D\u00e9veloppement analytique : notre expertise<\/h1>\n<\/div><\/div>
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Chez Minakem, notre \u00e9quipe de D\u00e9veloppement Analytique est un partenaire strat\u00e9gique essentiel pour votre Process Development.<\/p>\n

En collaborant \u00e9troitement avec vos scientifiques, nous concevons des m\u00e9thodes analytiques robustes et adapt\u00e9es, garantissant la fiabilit\u00e9 et la reproductibilit\u00e9 de vos r\u00e9sultats.<\/p>\n

Notre savoir-faire s’\u00e9tend du profilage des impuret\u00e9s \u00e0 la quantification pr\u00e9cise des API (et HPAPI) et \u00e0 l’\u00e9valuation rigoureuse de la stabilit\u00e9, pour une s\u00e9curit\u00e9 et une efficacit\u00e9 optimales.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Une strat\u00e9gie analytique intelligente<\/h2>\n<\/div><\/div>
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Notre approche analytique s’articule autour d’une Strat\u00e9gie de Contr\u00f4le Analytique \u00ab\u00a0Fit-for-Purpose\u00a0\u00bb, \u00e9labor\u00e9e en synergie avec nos experts en Affaires R\u00e9glementaires.<\/p>\n

Gr\u00e2ce \u00e0 une analyse de risque approfondie, nous adressons proactivement les pr\u00e9occupations r\u00e9glementaires cl\u00e9s : impuret\u00e9s g\u00e9notoxiques, nitrosamines et impuret\u00e9s \u00e9l\u00e9mentaires.<\/p>\n

Cette anticipation strat\u00e9gique facilite votre conformit\u00e9 et acc\u00e9l\u00e8re le processus d’approbation.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

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\u00c9tudes de stabilit\u00e9 : notre engagement pour la qualit\u00e9 durable de vos produits.<\/h2>\n<\/div><\/div>
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Nous r\u00e9alisons des \u00e9tudes de stabilit\u00e9 compl\u00e8tes pour d\u00e9terminer la dur\u00e9e de vie de vos API (petites mol\u00e9cules) et identifier les potentielles d\u00e9gradations via des \u00e9tudes de d\u00e9gradation forc\u00e9e.<\/p>\n

Notre objectif : garantir la p\u00e9rennit\u00e9 de l’int\u00e9grit\u00e9 et de la qualit\u00e9 de vos produits pharmaceutiques.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Validation de process :
\nun travail d’\u00e9quipe analytique<\/h2>\n<\/div><\/div>
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Lors de la phase critique de validation de process, nos \u00e9quipes de D\u00e9veloppement Analytique et de Contr\u00f4le Qualit\u00e9 unissent leurs forces pour assurer une transition industrielle sans heurt.<\/p>\n

La validation conjointe des m\u00e9thodes analytiques et des processus de fabrication est la cl\u00e9 d’une production constante et conforme aux sp\u00e9cifications.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Support r\u00e9glementaire pointu : des donn\u00e9es analytiques solides pour vos succ\u00e8s.
\n<\/strong><\/p>\n

Nous vous fournissons des donn\u00e9es analytiques exhaustives et fiables pour vos soumissions r\u00e9glementaires : \u00e9tudes de solubilit\u00e9, hygroscopicit\u00e9, caract\u00e9risation de la forme solide et profilage physicochimique.<\/p>\n

Notre parfaite connaissance des directives internationales (EDQM, FDA, ICH) est un atout majeur pour l’approbation et la commercialisation de vos m\u00e9dicaments.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

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Un centre d’cxcellence analytique
\npour acc\u00e9l\u00e9rer votre R&D.<\/h2>\n<\/div><\/div>
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Notre laboratoire de D\u00e9veloppement Analytique de pointe est \u00e9quip\u00e9 pour accompagner votre R&D des proc\u00e9d\u00e9s, de l’\u00e9chelle laboratoire \u00e0 la production commerciale, pour les API et HPAPI.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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Nos capacit\u00e9s comprennent un large \u00e9ventail de techniques analytiques :<\/h3>\n<\/div><\/div>
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Solvatation et l’Analyse Thermique<\/strong>
\nTGA, Vacuum Oven, Halogen Dryer, KF et oven KF<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

Chromatographie avanc\u00e9e<\/strong>
\nHPLC\/UPLC, IC, GC, GC-HS<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

Spectrom\u00e9trie multi-techniques\u00a0<\/strong>
\nFTIR, NMR, UV-visible, refractometer,
\npolarimeter, ICP-OES<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>

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Pour am\u00e9liorer la compr\u00e9hension du processus pendant la phase de R&D, nous utilisons des technologies analytiques de pointe, notamment :<\/p>\n

    \n
  • Spectrom\u00e9trie de Masse<\/li>\n
  • C-MS, GC-MS, HRMS<\/li>\n
  • ICP-MS<\/li>\n
  • XRPD<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div>

    Minakem : votre alli\u00e9 analytique<\/h2>\n<\/div><\/div>

    Notre approche de d\u00e9veloppement analytique int\u00e9gr\u00e9e est con\u00e7ue pour fluidifier le parcours de vos projets pharmaceutiques, de la R&D \u00e0 la commercialisation, avec un engagement constant envers la qualit\u00e9, la conformit\u00e9 et l’innovation.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"D\u00e9veloppement analytique : notre expertise Chez Minakem, notre \u00e9quipe de D\u00e9veloppement Analytique est un partenaire strat\u00e9gique essentiel pour votre Process Development. En collaborant \u00e9troitement avec vos scientifiques, nous concevons des m\u00e9thodes analytiques robustes et adapt\u00e9es, garantissant la fiabilit\u00e9 et la reproductibilit\u00e9 de vos r\u00e9sultats. Notre savoir-faire s’\u00e9tend du profilage des impuret\u00e9s \u00e0 la quantification pr\u00e9cise...","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-28844","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nSciences analytiques | Minakem<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/minakem.com\/fr\/sciences-analytiques\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sciences analytiques\" \/>\n<meta property=\"og:url\" content=\"https:\/\/minakem.com\/fr\/sciences-analytiques\/\" \/>\n<meta property=\"og:site_name\" content=\"Minakem\" \/>\n<meta property=\"article:publisher\" 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