BioHale® Sucrose
BioHale® Sucrose
With BioHale® Sucrose we offer the highest purity excipient for the stabilization of biologics to be used in biopharmaceutical formulation.
Product description
Product description
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. 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
Source
Plant, isolated from sugar beet
CAS number
57-50-1
Compliance with monographs
Ph. Eur., USP-NF, JP, ChP
Endotoxin level (EU/g)
≤ 0.25
Tg (°C)
~61
Product specifications
Product specifications
Endotoxin: ≤ 0.25 EU/g
Heavy Metals: ≤ 5 ppm
Elemental Impurities: Complies with ICH Q3D
Total Impurities: ≤ 2.0%
Reducing sugars: ≤ 0.07%
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.