Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Sucrose Excipient Molecular Structure used to stabilize proteins in biologics and therapeutics

Sucrose NF EP JP ChP

Sucrose, High Purity / Low Endotoxin-Low Metals NF, EP, JP, ChP, Beet Derived

Molecular Formula

C12H22O11

CAS No

57-50-1

Molecular Weight

342.3

Solubility in Water

200 g/100ml at 25°C

Boiling Point

N/A – decomposes

Melting Point

96.5 °C

Quality Level

Highest – Parenteral Excipient Grade cGMP

Suitable for Injectable Biologic & Vaccine Formulations

Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose, found in many plants but extracted as ordinary sugar mainly from sugar cane and sugar beets.

 

Pfanstiehl Brand, High Purity Low Endotoxin Sucrose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics.  It is also widely applied as a cryopreservative and media supplement in a variety of cell-based bioprocesses.

Pfanstiehl High Purity Low Endotoxin Low Metals Sucrose benefits in Biologic protein stabilization and cryopreservation:

Protein and Antibody Stabilization:

One of the key applications of low endotoxin sucrose (molecular weight 342.3 g/mol) lies in stabilizing proteins and antibodies. Proteins are inherently sensitive to environmental factors such as temperature, pH, and agitation, which can lead to denaturation and loss of biological activity. Sucrose acts as a stabilizing agent by forming hydrogen bonds with proteins, creating a protective environment that shields them from external stressors. This stabilizing effect helps maintain the native conformation of proteins and antibodies, preserving their functionality over time.

 

Vaccine Stability:

Sucrose (also known as saccharose) is widely employed in the stabilization of vaccines, where maintaining the integrity of antigens is crucial for effective immunization. Vaccines often face challenges during storage, transportation, and distribution, including exposure to temperature variations. The addition of sucrose to vaccine formulations creates a glassy matrix that reduces molecular mobility, preventing the denaturation of antigens. This stabilizing effect ensures that vaccines remain potent and efficacious, even under challenging conditions.

 

Lipid Stabilization:

Lipids, essential components of cell membranes and carriers for drug delivery, are prone to oxidation and degradation. By forming a protective barrier around lipid structures, sucrose prevents the formation of free radicals, preserving the integrity and functionality of lipids. This stabilization is crucial for the development of lipid-based drug delivery systems and other pharmaceutical applications.

 

Cryopreservation:

Sucrose serves as an effective cryopreservative agent, enabling the preservation of biological materials at low temperatures. In cryopreservation, sucrose acts as a cryoprotectant by reducing the formation of ice crystals that can damage cells. The ability of sucrose to maintain a glassy state during freezing protects cellular structures and prevents the detrimental effects of ice formation, allowing for the long-term storage of cells, tissues, and biological samples.

 

Preservation of Stem Cells in Cell Therapy:

In the field of cell therapy, low endotoxin sucrose plays a pivotal role in preserving the viability and functionality of stem cells. Stem cells are highly sensitive to changes in their microenvironment, and sucrose helps maintain a stable environment during the freezing and thawing processes. This ensures the successful preservation of stem cells, allowing for their use in various therapeutic applications without compromising their regenerative potential.

 

Sucrose is an indispensable tool for biological stabilization. Its ability to form protective matrices, prevent denaturation, and act as a cryopreservative makes it a valuable component in pharmaceuticals, vaccines, and cell therapy applications.

References/Citations:

Pfanstiehl Sucrose Citation Page

References/Citations:

Highest cGMP Compendial Quality for your Highest Risk Applications

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals Sucrose was developed specifically for biopharmaceutical formulation and commercial manufacturing and is produced under full ICH-Q7 cGMP conditions in the United States to the highest quality and purity standards.

 

Pfanstiehl Brand Sucrose is compliant with NF (National Formulary)  EP (European) JP (Japanese) and ChP (Chinese) Pharmacopoeia.  Pfanstiehl also holds a DMF for the Sucrose (S-124-2-MC) product.

 

Because of these stringent manufacturing specifications and quality systems, you can be assured that Pfanstiehl’s Sucrose will be of the highest quality & consistency from batch to batch and the safest available for use in your manufacturing or research application.

Product Name:

Sucrose (Plant Derived)

Quality Level:

Highest – Compendial Parenteral Excipient Grade GMP

Attributes:

Highest Purity

Lowest Endotoxin

Lowest Metals

Lowest Bioburden

Agency Pharmacopeia:

NF

EP

JP

ChP

Applications:

Parenteral Formulation

Liquid Formulation

Pharmaceutical Process

Biopharma Process

  • Product Name:

    Sucrose (Plant Derived)

  • Quality Level:

    Highest – Compendial Parenteral Excipient Grade GMP

  • Attributes:

    Highest Purity

    Lowest Endotoxin

    Lowest Metals

    Lowest Bioburden

  • Agency Pharmacopeia:

    NF

    EP

    JP

    ChP

  • Applications:

    Parenteral Formulation

    Liquid Formulation

    Pharmaceutical Process

    Biopharma Process

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Available Package Sizes:

100g, 1kg, 5kg, 10kg, 25kg, and 50kg

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