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 BP JP ChP

Injectable Excipient Grade - Multi-compendial - High Purity - Low Endotoxin - Low Metals

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 – GMP Parenteral Excipient Grade –
  • Suitable for Biologic & Vaccine Formulation
  • Suitable for Inhalation & Ophthalmic Formulation
  • Drug Master File (DMF) # 024122
  • Chinese CDE # F20170000098

 

Trehalose dihydrate GMP Excipient

Highest Purity – Lowest Endotoxin – Lowest Metals

 

Trehalose dihydrate is a sugar made of two glucose units connected by a strong α-1,1 bond making it stable in acidic and high-temperature conditions. Unlike other sugars it does not undergo glycation because its structure keeps the glucose molecules in a closed-ring form. The carbohydrate is less soluble than sucrose but more soluble at temperatures above 80°C. It’s stability and resistance to breakdown make it useful in biological preservation because of its cryoprotective properties.

 

Trehalose excipient grade has a high glass transition temperature (Tg) which is typically around 115°C when it is anhydrous. The glass transition temperature is when a substance changes from a rubbery flexible state to a solid glass-like state. This property is helpful in preserving protein therapeutics by trapping proteins in a stable glassy form which helps prevent degradation.

 

Below the Transition Glass Temperature (Tg), molecules in the glassy state have minimal movement. This minimizes the risk of proteins aggregating or denaturing which can harm the product’s effectiveness. Trehalose is ideal for protecting sensitive biologics during freeze-drying (lyophilization) and storage and helps preserve protein structure and function for therapeutic use.

 

Low Endotoxin Trehalose Excipient by Pfanstiehl

Trehalose Excipient is a high-purity, low endotoxin, low metals excipient that meets the stringent quality and regulatory requirements outlined in multiple pharmacopeias (e.g., USP, EP, BP, JP, ChP). It is specifically manufactured and tested to ensure it is suitable for use in parenteral (injectable) drug products, where safety, sterility, and low impurity levels are critical.

 

Low Endotoxin Trehalose excipient 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.

 

GMP Trehalose dihydrate by Pfanstiehl:

  1. Complies with Multiple Pharmacopeia

      • USP-NF (United States Pharmacopeia / National Formulary)
      • EP (European Pharmacopoeia)
      • BP (British Pharmacopoeia)
      • JP  (Japanese Pharmacopoeia)
      • ChP (Chinese Pharmacopoeia)
  2. Highest Purity and Lowest Impurities

      • Pharmaceutical grade with stringent control of:
        • Endotoxins
        • Microbial contamination
        • Transition Metals
        • Residual solvents
  3. Lowest Endotoxin Levels

      • Suitable for parenteral injectable applications, which ensures the lowest bacterial endotoxin levels to prevent pyrogenic reactions.
  4. Controlled Manufacturing (cGMP)

      • Produced in our Chicago, Illinois, USA manufacturing facilities adhering to ICH-Q7  Good Manufacturing Practices (GMP) to ensure consistent quality and purity.
  5.  Regulatory Compliance

      • Both Drug Master Files (DMF) and active Chinese CDE are maintained by Pfanstiehl.
        • DMF # 024122
        • CDE # F20170000098

Multi-Compendial Trehalose dihydrate Key Benefits:

  • Cellular Protection:
    Trehalose by Pfanstiehl helps protect cells and biological materials from damage caused by freezing and thawing. When cells freeze, ice crystals can form and rupture cell membranes, causing damage. The sugar prevents ice crystal formation, keeping cell membranes intact and maintaining the cell’s structure. It also helps protect proteins and lipids inside the cells, preserving their function. This makes Trehalose essential in preserving cell viability during cryopreservation.

 

  • Protein Stabilization:
    Well known for stabilizing proteins during freezing and thawing. Proteins can become damaged or lose shape when exposed to low temperatures which can cause issues like denaturation and clumping. The sugar works by forming a protective layer around proteins that keeps them stable and maintains their proper structure. This is particularly important in protein-based drugs like vaccines, where the protein’s structure is critical for its effectiveness.

 

  • Prevention of Freeze-Thaw Damage:
    The carbohydrate is an effective cryoprotectant that reduces the harmful effects of freezing and thawing on biological materials. Freezing can cause ice crystals to form which damage cells and proteins.  It prevents the formation of large ice crystals and minimizes damage. This is important for preserving biological samples and ensuring that cells and proteins remain intact and functional.

 

  • Improved Viability and Functionality:
    The sugar improves the survival and function of cells and biological molecules after thawing. Freezing can damage cells and reduce their effectiveness but trehalose protects them and ensures they retain their function when thawed. This is especially valuable for vaccines, antibodies and other biopharmaceutical products where maintaining the activity of the molecules is essential for successful treatment.

 

  • Enhanced Long-Term Storage:
    The sugar helps store biological materials at very low temperatures for extended periods without losing their function. Long-term storage can cause biological products to degrade but Trehalose protects them from damage during freezing and dehydration. This is critical in the biotechnology and pharmaceutical industries where drug product must remain stable over time for use in vaccines or gene therapies.

References/Citations:

Pfanstiehl Trehalose dihydrate Citation Page

Product Name:

Trehalose dihydrate (Plant derived)

Quality Level:

  • Highest – Parenteral Excipient Grade (GMP)
  • Suitable for  Injectable Biologic & Vaccine Formulation
  • Suitable for Inhalation & Ophthalmic Formulation

 

  • Trehalose dihydrate Excipient Grade
    • Drug Master File (DMF) # 024122
    • Chinese CDE # F20170000098

 

  • Trehalose dihydrate Inhalation Excipient Grade
    • Drug Master File (DMF) # 035182
    • Chinese CDE # F20170000115

 

  • Trehalose dihydrate Low Glucose Excipient Grade
    • Drug Master File (DMF) # 035277
    • Chinese CDE # F20170000479

Attributes:

  • Highest Purity
  • Lowest Endotoxin
  • Lowest Metals
  • Lowest Bioburden
  • Lowest Nitrosamines

Agency Pharmacopeia:

  • NF
  • EP
  • BP
  • JP
  • ChP

Applications:

  • Parenteral Formulation
  • Ophthalmic Formulation
  • Inhalation Formulation
  • Cryopreservation
  • Lyophilization
  • Final Formulation
  • Product Name:

    Trehalose dihydrate (Plant derived)

  • Quality Level:

    • Highest – Parenteral Excipient Grade (GMP)
    • Suitable for  Injectable Biologic & Vaccine Formulation
    • Suitable for Inhalation & Ophthalmic Formulation

     

    • Trehalose dihydrate Excipient Grade
      • Drug Master File (DMF) # 024122
      • Chinese CDE # F20170000098

     

    • Trehalose dihydrate Inhalation Excipient Grade
      • Drug Master File (DMF) # 035182
      • Chinese CDE # F20170000115

     

    • Trehalose dihydrate Low Glucose Excipient Grade
      • Drug Master File (DMF) # 035277
      • Chinese CDE # F20170000479
  • Attributes:

    • Highest Purity
    • Lowest Endotoxin
    • Lowest Metals
    • Lowest Bioburden
    • Lowest Nitrosamines
  • Agency Pharmacopeia:

    • NF
    • EP
    • BP
    • JP
    • ChP
  • Applications:

    • Parenteral Formulation
    • Ophthalmic Formulation
    • Inhalation Formulation
    • Cryopreservation
    • Lyophilization
    • Final Formulation
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Available Package Sizes:

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

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