Trehalose Dihydrate (For Injection)

Description

Trehalose Dihydrate for Injection is a high-purity, GMP-manufactured pharmaceutical excipient widely used in advanced biologics, vaccine formulations, and cell therapy systems. As a non-reducing disaccharide with exceptional stability and bioprotective properties, trehalose plays a critical role in preserving the structural integrity of proteins, cells, and lipid-based systems under extreme processing and storage conditions.

With compliance to major global pharmacopeias and regulatory registrations, Trehalose Dihydrate has become a key functional ingredient in modern biopharmaceutical development.

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1. Product Identification and Chemical Information

• Product Name: D(+)-Trehalose Dihydrate (Injection Grade)

• CAS Number: 6138-23-4

• Molecular Formula: C₁₂H₂₂O₁₁·2H₂O

• Molecular Weight: 378.33

• Chemical Structure: α-D-glucopyranosyl-α-D-glucopyranoside dihydrate

• Grade: Pharmaceutical / Injection Grade

• Product Code: O08001

• Appearance: White crystalline powder

Trehalose is a naturally occurring non-reducing sugar composed of two glucose molecules linked via an α,α-1,1-glycosidic bond, which contributes to its exceptional chemical stability.

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2. Regulatory Compliance and Quality Standards

Trehalose Dihydrate for Injection complies with major international pharmacopoeial standards:

• United States Pharmacopeia (USP)

• European Pharmacopoeia (EP)

• Japanese Pharmacopoeia (JP)

• Chinese Pharmacopoeia (ChP)

Regulatory Registrations:

• NMPA CDE Registration: F20190000452

• US FDA Drug Master File (DMF): 034401

These registrations ensure its suitability for global pharmaceutical manufacturing and regulatory submissions.

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3. Core Functional Mechanism

Trehalose is widely recognized for its biomolecule stabilization and cryoprotection capabilities, particularly in sensitive biological systems.

Key mechanisms include:

• Formation of a protective glass-like matrix around biomolecules

• Stabilization of proteins and membrane structures

• Reduction of ice crystal formation during freezing

• Increase in glass transition temperature (Tg)

• Prevention of protein denaturation and aggregation

• Protection of lipid bilayers under dehydration stress

These properties make trehalose especially effective in freeze-drying (lyophilization) and cryopreservation processes.

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4. Pharmaceutical and Biotech Applications

4.1 Biopharmaceutical Formulations

Trehalose is widely used as a stabilizing excipient in:

• Monoclonal antibodies (mAbs)

• Recombinant proteins

• Vaccines

• Gene and cell therapy products

• Liposomal drug delivery systems

• Extracellular vesicles (EVs) and exosomes

Its stabilizing effect helps maintain biological activity during production, storage, and transportation.

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4.2 Cell Therapy and Regenerative Medicine

In advanced therapeutic applications, trehalose is used for:

• CAR-T cell preservation

• Stem cell cryoprotection

• Cell suspension stabilization

• Long-term biological sample storage

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4.3 Lyophilization and Cryoprotection

Trehalose is a preferred excipient for:

• Freeze-drying (lyophilization) formulations

• Cryopreservation of biological materials

• Protein and enzyme stabilization under low-temperature stress

It helps maintain structural integrity and bioactivity after reconstitution.

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5. Product Specifications and Handling

• Appearance: White crystalline powder

• Packaging: 10 kg per bag (standard industrial packaging)

• Storage Conditions: Cool, dry, and protected from light

• Transport: Ambient temperature, sealed containers

The material is designed for pharmaceutical manufacturing environments requiring strict quality control.

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6. Key Advantages

Trehalose Dihydrate for Injection offers multiple advantages for pharmaceutical applications:

• High chemical and thermal stability

• Excellent resistance to hydrolysis (non-reducing sugar)

• Low hygroscopicity compared to other sugars

• High glass transition temperature for superior stabilization

• GMP-compliant manufacturing

• Extremely low endotoxin levels (typically <0.1 IU/g)

• Multi-pharmacopeia compliance (USP/EP/JP/ChP)

• Global regulatory readiness (FDA DMF supported)

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7. Industrial Value Proposition

From a biopharmaceutical perspective, Trehalose Dihydrate is a next-generation stabilizing excipient designed to address critical formulation challenges in modern biologics.

It significantly improves:

• Protein stability

• Cell viability during freezing and thawing

• Long-term storage performance

• Overall formulation robustness under stress conditions

As biologics and cell therapies continue to expand globally, trehalose has become an essential excipient for ensuring product quality and therapeutic efficacy.

Trehalose Dihydrate for Injection (CAS 6138-23-4) is a high-purity, GMP-grade pharmaceutical excipient widely used in advanced biologics, vaccine development, and cell therapy applications. With strong regulatory compliance and superior stabilization performance, it plays a critical role in protecting sensitive biological systems across manufacturing, storage, and clinical use.

Its unique combination of cryoprotection, protein stabilization, and formulation compatibility makes it a cornerstone material in modern biopharmaceutical innovation.