Product Details
- Manufacturer
- SKU
- 6138-23-4
- Expiration Date
- November 1, 2025
About this product
Trehalose Dihydrate NF EP JP ChP
High-Purity, Plant-Derived Trehalose Dihydrate – Low Endotoxin, Low Metals | NF, EP, JP, ChP
Molecular Formula: C₁₂H₂₂O₁₁ · 2H₂O
CAS Number: 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 & Regulatory Compliance
- Highest Purity – Parenteral Excipient Grade cGMP
-
Suitable for:
- Injectable biologic and vaccine formulations
- Inhalation and ophthalmic formulations
-
Regulatory Filings:
- Drug Master File (DMF) #24122
- Chinese CDE #F20170000125
Product Overview
Trehalose dihydrate is a disaccharide composed of two glucose molecules linked by a robust α-1,1 bond, providing exceptional stability under acidic and high-temperature conditions. Unlike other sugars, it does not undergo glycation due to its closed-ring structure, preserving the integrity of sensitive biological formulations.
Trehalose is less soluble than sucrose at lower temperatures but exhibits higher solubility above 80°C. Its remarkable stability and resistance to degradation make it an ideal excipient for biological preservation, offering cryoprotective benefits in various pharmaceutical and biotechnological applications.
Expiration Date: 01/11/2025
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