Low endotoxin Trehalose

Product description

VIO Chemicals offers high quality low endotoxin and GMO-free Trehalose dihydrate and Trehalose anhydrous, for pharmaceutical and cosmetic applications, in a very competitive price.    Technical profile:
  • Technical name: α, α-D-Trehalose dihydrate
  • CAS No: 6138-23-4
  • Empirical formula: C12H22O11 * 2H2O 
  • Molecular weight: 342.3 + 36.0
Advantages: Trehalose is a non-reducing disaccharide consisting of two molecules linked by an α, α-1, 1 bond. There are several properties of trehalose that make it an excellent stabilizer in biopharmaceutical formulations. In particular, trehalose is used to stabilize protein-based pharmaceuticals, such as monoclonal antibodies in injectables and other protein molecules that are often degraded by freezing, lyophilization and storage for long periods.  Features: Trehalose demonstrates exceptional stability. It is not easily hydrolyzed by acid and the glycosidic bond is not cleaved by α-glycosidase. Trehalose is typically found in the dihydrate form and is characterized by its low hygroscopicity. The water content of the dihydrate crystal remains stable at approximately 9.5% during exposure to relative humidity up to 92%. During various desiccation processes, including freeze drying and spray drying, Trehalose readily dries as an amorphous material with high glass transition temperature (Tg > 100°C), the highest of the disaccharides. Compared to sucrose, Trehalose’s Tg is about 3°C higher. This important physicochemical property is relevant for shortening drying times dramatically.  Benefits: The stabilizing benefits of Trehalose include but are not limited to:
  • Monoclonal antibodies (mAbs)
  • Fusion proteins
  • Antibody fragments (fAbs)
  • Peptides
  • Stem cells
  • Vaccines
Applications: Trehalose is contained in several commercially available therapeutic products, including Herceptin®, Avastin®, Lucentis® and Advate®.  Compliance:  EP, USP/NF, JP
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Specifications

CAS Registry Number 6138-23-4
Categories Excipients/Formulation
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