BioHale high purity and low endotoxin excipients from DFE Pharma facilitate the stabilization of biomolecules, reducing the loss of activity and improving efficacy.

BioHale Trehalose Dihydrate is a disaccharide formed by a 1,1-glycosidic bond between two α-glucose units. It is a nonreducing sugar that is not easily hydrolyzed by acid.

BioHale Trehalose Dihydrate is well suited to provide solution-state stabilization, as well as cryo- and lyo-protection for biomolecules to use in parenteral, inhalation and ophthalmic applications.

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

Product Information
• Description: White, or almost white, crystals or crystalline powder
• Multi-compendial specifications compliant with USP-NF, JP, ChP monographs
• Produced in state-of-the-art, FDA-inspected manufacturing facilities in accordance with ICH Q7, which provides cGMP guidance for the manufacturing of APIs
• Active purification steps ensure excipients are independent of raw material variation
• Molecular Formula: C₁₂H₂₂O₁₁⋅2H₂O
• Molecular Weight: 378.33 g/mol
• CAS Number: 6138-23-4
• Tg: ~107°C

Product Specifications
• 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%