BioHale® Trehalose Dihydrate
BioHale® Trehalose Dihydrate
High purity, low endotoxin Trehalose Dihydrate
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.
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Product description
Product description
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).
Typical product data
Typical product data
Description: White, or almost white, crystals or crystalline powder
Molecular Formula: C12H22O11 · 2H2O Molecular Weight: 378.33 g/mol
CAS Number: 6138-23-4 Tg: ~107°C
Product specifications
Product specifications
Endotoxin≤ 0.30 EU/g
Heavy Metals ≤ 5 ppm
Elemental Impurities Complies with ICH Q3D
Total Impurities ≤ 0.5% (for RRT<1.0) and ≤ 0.5% (for RRT>1.0)
Reducing sugars ≤ 0.1%
Packaging
Packaging
1kg (HDPE container) with PE inner liner
Product delivery
Product delivery
Expected delivery within 5-7 days. Each order ships with Certificate of Analysis, Material Safety Data Sheet and Product Data Sheet.
