Delivering on the Promise of Purity

Delivering on the Promise of PurityTM

Trehalose Injectable Excipient Molecular Structure used to stabilize proteins in biologics and therapeutics

Trehalose Dihydrate NF EP JP ChP

a, a Trehalose (Plant Derived) High Purity / Low Endotoxin-Low Metals NF, EP, JP, ChP

Molecular Formula

C12 H22O11 . 2H2O

CAS No

6138-23-4

Molecular Weight

378.33

Solubility in Water

68.9 g per 100 g at 20 °C

Boiling Point

675.4 °C

Melting Point

96.5 °C

Quality Level

Highest – Parenteral Excipient Grade cGMP

Suitable for Injectable Biologic & Vaccine formulation

Trehalose Dihydrate is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond and has gained acceptance in biologic stabilization applications due to its unique cryopreservative properties.

 

Pfanstiehl’s Trehalose dihydrate has been found to offer several benefits in the preservation of monoclonal antibodies, fusion proteins, vaccines, and stem cells.

Pfanstiehl Trehalose benefits include:

Cellular Protection

Trehalose has been shown to protect cells and biological materials from damage caused by freezing and thawing. Its presence helps maintain the structural integrity of cell membranes and prevents the formation of ice crystals, which can be detrimental to cells.

 

Protein Stabilization:

Trehalose is known for its protein-stabilizing properties. It can help maintain the conformational stability of proteins during freezing and thawing processes, reducing the risk of protein denaturation and aggregation.

 

Prevention of Freeze-Thaw Damage:

Administering highly Trehalose acts as a cryoprotectant, mitigating the harmful effects of freezing and thawing on cells and proteins. This is particularly important in the preservation of biological samples, where ice crystal formation and the associated cellular damage can be a significant concern.viscous formulations may require higher injection forces, leading to patient discomfort and potential issues with administration compliance.

 

Improved Viability and Functionality:

When used in cryopreservation, Trehalose has been shown to improve the viability and functionality of cells and biological molecules after thawing. This is crucial for maintaining the effectiveness of vaccines, antibodies, and other biopharmaceutical products.

 

Enhanced Long-Term Storage:

Trehalose allows for the long-term storage of biological materials at ultra-low temperatures without significant loss of viability or functionality. This is particularly valuable in biotechnology and pharmaceutical industries where the stability of products over time is crucial.

References/Citations:

Pfanstiehl Trehalose Citation Page

Highest cGMP Compendial Quality for your Highest Risk Applications

Pfanstiehl Brand High Purity – Low Endotoxin – Low Metals

  • Trehalose Dihydrate,
  • Trehalose Dihydrate (Low Glucose)
  • Trehalose Dihydrate Inhalation Grade

 

were developed specifically for biopharmaceutical formulation and commercial manufacturing and are produced under full ICH-Q7 cGMP conditions in the United States to the highest quality and purity standards.

 

Pfanstiehl Brand Trehalose is compliant with NF (National Formulary) EP (European) JP (Japanese) and ChP (Chinese) Pharmacopoeia

 

Because of these stringent manufacturing specifications and Pfanstiehl Quality Systems, you can be assured that Pfanstiehl’s Trehalose 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:

Trehalose dihydrate

Quality Level:

Highest – Compendial Parenteral Excipient Grade GMP

Attributes:

Highest Purity

Low Endotoxin

Low Metals

Low Bioburden

Agency Pharmacopeia:

USP-NF

EP

JP

ChP

Applications:

Parenteral Formulation

Liquid Formulation

Pharmaceutical Process

Biopharma Process

  • Product Name:

    Trehalose dihydrate

  • Quality Level:

    Highest – Compendial Parenteral Excipient Grade GMP

  • Attributes:

    Highest Purity

    Low Endotoxin

    Low Metals

    Low Bioburden

  • Agency Pharmacopeia:

    USP-NF

    EP

    JP

    ChP

  • Applications:

    Parenteral Formulation

    Liquid Formulation

    Pharmaceutical Process

    Biopharma Process

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