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BioHale® Sucrose

Hochreine, endotoxinarme Sucrose

Biopharma

Produktinformation

Mit BioHale® Sucrose bieten wir einen Hilfsstoff höchster Reinheit für die Stabilisierung von Biologika zur Anwendung in biopharmazeutischen Formulierungen. BioHale® Sucrose ist ein nicht-reduzierendes, kristallines Disaccharid, bestehend aus je einem glykosidisch gebundenem Glucose- und Fructose-Molekül.

Sucrose wird in der pharmazeutischen Industrie häufig als Stabilisator verwendet, kann aber auch als Stabilisator in der Gefriertrocknung und Zusatzmittel in einer Vielzahl von zellbasierten Bioprozessen eingesetzt werden.

Darüber hinaus wird BioHale® Sucrose bevorzugt in Anwendungen eingesetzt, bei denen Löslichkeits- oder Viskositätsprobleme von Bedeutung sind. BioHale® Sucrose eignet sich gut zur Stabilisierung des Lösungszustands für therapeutische Proteine, sowie zum Kryo- und Lyo-Schutz in den Formulierungen. Sucrose kann in den meisten Formulierungen mit Ausnahme von Lösungen mit niedrigem pH-Wert eingesetzt werden.

BioHale® Sucrose kann in verschiedenen Darreichungsformen verwendet werden, z. B. parenteral, oral oder ophthalmisch. Über unser Hilfsstoffportfolio hinaus profitieren unsere Kunden von unseren technischen Lösungen und unserer regulatorischen Unterstützung, um dem Wettbewerb einen Schritt voraus zu sein. Unsere BioHale®-Hilfsstoffe erfüllen die globalen regulatorischen Anforderungen der pharmazeutischen Industrie (Ph. Eur., USP-NF, JP, ChP) und verfügen über ein Chinese Drug Master File (cDMF).

Mit BioHale® Sucrose unterstützen wir derzeit die COVID-19-Impfstoffproduktion auf der ganzen Welt. Lesen Sie mehr dazu: DFE Pharma unterstützt die Versorgung mit COVID-19-Impfstoff in Pakistan

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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

Quelle

Quelle: Pflanzlich, isoliert aus Zuckerrüben

CAS Nummer

CAS Nummer: 57-50-1

Tg (°C)

Tg (°C): ~61

Documentation

Abwesenheit von Melamin Pharmacel, SuperStarch, Zerfallsmitteln
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Abwesenheit von Aromen, Farbstoffen, Süßungsmitteln, Konservierungsmitteln und Glykolen
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BSE-Erklärung BioHale (Sucrose, Trehalose
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Sammelnachweis Saccharose (Allergene, Latex etc.)
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Konformitätserklärung Verpackung
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Kontaminanten Saccharose
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COS Saccharose
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Ursprungsland Saccharose
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FDA UNI-Nummern
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Erklärung über genotoxische Verunreinigungen
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GVO-Angabe Saccharose
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ICHQ3D Elementare Verunreinigungen
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(Inhaltsstoffdeklaration Saccharose
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IPEC-Fragebogen zu Nitrosaminen
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Nano-Materialien
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Keine US DMF-Anforderung
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Keine Verwendung von PFC, DEHP, DINP und BPA
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Keine gefährliche Substanz
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Stabilitätsangabe BioHale Sucrose
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Erklärung über Lösungsmittelrückstände BioHale Sucrose
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Sicherheitshinweis Saccharose
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