BioHale® Trehalose Dihydrate

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.

Stabilizing agent
BioHale® Trehalose Dihydrate is a non-reducing sugar and as such does not facilitate the Maillard reaction; therefore offers improved compatibility with amino acids and proteins compared to a reducing sugar. BioHale® Trehalose provides solution-state stabilization to fragile biomolecules. It is relatively stable under low-pH conditions compared to other disaccharides.

Cryo- and lyoprotectant
BioHale® Trehalose Dihydrate can play an important role in protecting your biologic from the freeze and dehydration stresses that occur during lyophilization. Additionally once in the lyophilized form the high glass transition temperature of BioHale® Trehalose Dihydrate can help maintain a glassy matrix and prevent re-crystallization.

• 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

Endotoxin: ≤ 0.30 EU/g
Heavy Metals: ≤ 5 ppm
Elemental Impurities: Complies with ICH Q3D
Total Impurities: ≤ 0.5% (RRT<1.0)
≤ 0.5% (RRT>1.0)
Reducing sugars: ≤ 0.1%

• High purity, low endotoxin grade produced by active purification process
• Manufactured in The Netherlands, Europe
• FDA inspected and state-of-the-art cGMP facility
• Multi-compendial specification complies with Ph. Eur., USP-NF, JP, ChP
• Chinese DMF available

1kg (HDPE container) with PE inner liner
20kg (HDPE drum) with PE inner liner

Product Specifications

Product Safety Information