BioHale® Sucrose

BioHale® Sucrose is a non-reducing crystalline disaccharide made up of one glucose and one fructose molecule joined via a glycosidic linkage. Commonly used in the pharmaceutical industry as a stabilizer, Sucrose can be also widely used as a cryopreservative and media supplement in a variety of cell-based bioprocesses. Additionally, BioHale® Sucrose is preferred in applications where solubility or viscosity issues are of supreme importance.

BioHale® Sucrose is well suited to provide solution-state stabilization, as well as cryo- and lyo-protection for therapeutic proteins as excipients in the formulations. Sucrose can generally be considered as suitable in most cases, unless constrained by a low-pH formulation. BioHale® Sucrose can be used in various administration forms, such as for parenteral, oral or ophthalmic route.

Stabilizing agent
BioHale® Sucrose is a non-reducing sugar and does not react with amino acids or proteins, inhibiting the Maillard reaction. BioHale® Sucrose provides solution-state stabilization to fragile biomolecules.
Cryo- and lyoprotectant
BioHale® Sucrose, a high purity disaccharide excipient, protects the biologic drugs from the freeze related (cryoprotectant) and drying related (lyoprotectant) stresses. This makes BioHale® Sucrose particularly suitable in the stabilization process of today’s biologics.

• Description: White, or almost white, crystalline
powder, or lustrous, colorless or white, or
almost white, crystals
• Source: Plant derived, isolated from sugar beet
• Molecular Formula: C12H22O11
Molecular Weight: 342.30 g/mol
• CAS Number: 57-50-1

Endotoxin: ≤ 0.25 EU/g
Heavy Metals: ≤ 5 ppm
Elemental Impurities: Complies with ICH Q3D
Total Impurities: ≤ 2.0%
Reducing sugars: ≤ 0.07

• High purity, low endotoxin grade produced by
active purification process
• Manufactured in The Netherlands, Europe
• FDA audited 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