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BioHale® Trehalose Dihydrate

High purity, low endotoxin Trehalose Dihydrate

Biopharma

Product information

With BioHale® Trehalose Dihydrate we offer the highest purity excipient for the stabilization of biologics in biopharmaceutical formulations. BioHale® Trehalose Dihydrate is a disaccharide formed by a 1,1-glycosidic bond between two α-glucose units. It is a non-reducing sugar that is not easily hydrolyzed by acid, and the glycosidic bond is not cleaved by α-glucosidase.

BioHale® Trehalose Dihydrate is suitable for use in a wide variety administration routes including parenteral, inhalation and ophthalmic. In particular, it is commonly used for the lyoprotection and cryoprotection of therapeutic proteins, especially for parenteral administration.

Other applications include use as stabilizing agent during the freeze–thaw and lyophilization of liposomes; and for stabilization of blood cells as well as monoclonal antibodies. Beyond our excipient portfolio, customers benefit from our technical solutions and regulatory support to unlock their competitive advantage.

Our BioHale® excipients comply with the global regulatory requirements of the pharmaceutical industry (Ph. Eur., USP-NF, JP, ChP) and hold a Chinese Drug Master File (cDMF).

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Excipient functionality: Stabilizer
Recommended process: Lyophilization
Dosage forms: Parenteral

Typical product data

CAS number

CAS number: 6138-23-4

Compliance with monographs

Compliance with monographs: Ph. Eur., USP-NF, JP, ChP

Endotoxin level (EU/g)

Endotoxin level (EU/g): ≤ 0.3

Tg (°C)

Tg (°C): ~107

Documentation

Brochure Biohale® View
Product page Biohale Trehalose View
Absence of Melamine Pharmacel, SuperStarch, Disintegrants
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BSE statement BioHale (Sucrose, Trehalose)
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Collective statement Trehalose
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Contaminants Statement Trehalose
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COS Trehalose
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FDA UNI numbers
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Genotoxic impurities statement
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GMO statement Trehalose
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ICHQ3D - Elemental Impurities Starches
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Ingredient declaration Trehalose
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IPEC questionnaire on Nitrosamines
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Laboratories used for end product testing
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Nano materials
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Stability Summary Trehalose
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Process flow sheet Trehalose
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Production sites & warehouses
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Residual solvents
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Safety Information Trehalose
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Stability Summary Trehalose
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