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BioHale® Trehalose Dihydrate

Hochreines, endotoxinarmes Trehalose-Dihydrat

Biopharma

Produktinformation

Mit BioHale® Trehalose Dihydrat bieten wir den hochreinen Hilfsstoff für die Stabilisierung von Biologika in biopharmazeutischen Formulierungen. BioHale® Trehalose Dihydrat ist ein Disaccharid, das durch eine 1,1-glykosidische Bindung zwischen zwei α-Glucoseeinheiten gebildet wird. Es handelt sich um einen nicht-reduzierenden Zucker, der nicht leicht durch Säure hydrolysiert wird, und die glykosidische Bindung wird nicht durch α-Glucosidase gespalten.

Mit BioHale® Trehalose Dihydrat bieten wir den hochreinen Hilfsstoff für die Stabilisierung von Biologika in biopharmazeutischen Formulierungen. BioHale® Trehalose Dihydrat ist ein Disaccharid, das durch eine 1,1-glykosidische Bindung zwischen zwei α-Glucoseeinheiten gebildet wird. Es handelt sich um einen nicht-reduzierenden Zucker, der nicht leicht durch Säure hydrolysiert wird, und die glykosidische Bindung wird nicht durch α-Glucosidase gespalten.

BioHale® Trehalose Dihydrat eignet sich für eine Vielzahl von Verabreichungswegen, darunter parenterale, inhalative und ophthalmische. Insbesondere wird es häufig zum Lyoprotektion und Kryoprotektion von therapeutischen Proteinen verwendet, vor allem bei der parenteralen Verabreichung.

Weitere Anwendungen sind die Stabilisierung von Liposomen beim Einfrieren und Lyophilisieren sowie die Stabilisierung von Blutzellen und monoklonalen Antikörpern. Über unser Hilfsstoffportfolio hinaus profitieren unsere Kunden von unseren technischen Lösungen und unserer regulatorischen Unterstützung, um ihren Wettbewerbsvorteil zu nutzen.

Unsere BioHale®-Hilfsstoffe erfüllen die weltweiten regulatorischen Anforderungen der pharmazeutischen Industrie (Ph. Eur., USP-NF, JP, ChP) und verfügen über ein Chinese Drug Master File (cDMF).

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Wenn Sie unseren Biopharma-Experten treffen möchten, klicken Sie bitte hier.

Funktionalität des Hilfsstoffs: Stabilisator
Empfohlenes Verfahren: Lyophilisierung
Darreichungsformen: Parenteral

Typische Produktdaten

CAS Nummer

CAS Nummer: 6138-23-4

Tg (°C)

Tg (°C): ~107

Dokumentation

Abwesenheit von Melamin Pharmacel, SuperStarch, Zerfallsmitteln
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BSE-Erklärung BioHale (Sucrose, Trehalose
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Sammelnachweis Trehalose
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Erklärung zu Verunreinigungen Trehalose
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COS Trehalose
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FDA UNI-Nummern
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Erklärung über genotoxische Verunreinigungen
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GVO-Erklärung Trehalose
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ICHQ3D - Elementare Verunreinigungen Stärken
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Inhaltsstoffdeklaration Trehalose
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IPEC-Fragebogen zu Nitrosaminen
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Laboratorien, die für die Prüfung des Endprodukts verwendet werden
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Nano-Materialien
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Stabilitätsübersicht Trehalose
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Prozessablaufplan Trehalose
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Produktionsstandorte & Lagerhäuser
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Rückstände von Lösungsmitteln
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Sicherheitsinformationen Trehalose
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Stabilitätsübersicht Trehalose
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