海藻糖二水合物Trehalose Dihydrate
Injectable-grade, high-purity, low-endotoxin · benchmarked to Nagase Viita / Pfanstiehl / BioSpectra
A drop-in alternative to Nagase Viita, Pfanstiehl and BioSpectra
Product Profile
- CAS No.
- 6138-23-4
- Alias
- α-D-glucopyranosyl-α-D-glucopyranoside dihydrate
- Formula / molecular weight
- C12H22O11·2H2O / molecular weight 378.33
- Grade
- 注射级（Injectable Grade）
- Function
- Lyoprotectant for biologics — non-reducing disaccharide
- Appearance
- White crystalline powder (solution clear and colorless)
- Solubility
- Freely soluble in water (approx. 689 g/L)
- Compendial standards
- USP-NF / EP / JP / ChP
- Therapeutic area
- Biologics / monoclonal antibodies
- Packaging / form
- Packaged to customer requirement (injectable grade; moisture-sealed)
- Delivery
- MOQ and lead time negotiable (commercial-scale supply supported)
Key Application Scenarios
mAb solution stabilization
Trehalose has a markedly larger molecular volume (about 2.5× sucrose), producing a stronger preferential-hydration effect that achieves the same conformational stabilization at substantially lower concentrations.
Lyophilization protection
Provides a higher glass-transition temperature (approx. 120 °C vs. approx. 70 °C for sucrose) and excellent thermal / acid stability (stable for 24 h at pH 2, 100 °C).
Protein and cell-membrane protection
As a non-reducing disaccharide it does not undergo Maillard reactions with proteins, protecting proteins, lipids and cell membranes during freeze-drying, freeze–thaw and storage.
Key Injectable-Grade Specifications
| Test | Typical specification | Reference standard |
|---|---|---|
| Appearance | White crystalline powder; solution clear and colorless | |
| Assay (HPLC, anhydrous basis) | Not less than 99.0% (NLT 99.0%) | |
| Water content (Karl Fischer) | 9.0% – 11.0% | |
| Specific rotation | +197° ~ +201° | |
| pH (100 mg/mL solution) | 4.5 – 6.5 | |
| Related substances | Glucose, maltotriose and other polysaccharides tightly controlled | |
| Bacterial endotoxins | < 2.5 IU/g (ultra-low-endotoxin grade available on request) | Injectable-grade control |
| Microbial limits | TAMC ≤ 100 cfu/g; TYMC ≤ 10 cfu/g; E. coli and Salmonella absent | Injectable-grade control |
The above are typical specifications; actual measured values are issued per batch with the CoA.
Zero Registration Risk · Audits Fully Open
Registered with NMPA (China NMPA)
China DMF filing completed; supports customer formulation registration
On-site customer audits welcome
Full regulatory documentation support provided
Key Selling Points
- ✓Complies with current ChP / USP-NF / EP / JP
- ✓CoA and inter-batch consistency data provided
- ✓Quality equivalent to Nagase Viita, Pfanstiehl and BioSpectra
- ✓Direct drop-in replacement — no reformulation required
- ✓Ready for biologic formulation development and commercial supply
Blockbuster mAb products using this excipient
| Product / formulation | INN / company | Dosage form |
|---|---|---|
| Ocrevus | 奥瑞利珠单抗 Ocrelizumab · 罗氏 Roche | IV concentrate + subcutaneous injection |
| Cosentyx | 司库奇尤单抗 Secukinumab · 诺华 Novartis | Subcutaneous pen / prefilled syringe + IV infusion |
| Herceptin | 曲妥珠单抗 Trastuzumab · 罗氏 Roche | Lyophilized powder + subcutaneous injection |
| Avastin | 贝伐珠单抗 Bevacizumab · 罗氏 Roche | IV concentrate · contains 6% trehalose |
The product names above are for illustrating this excipient's actual use scenarios and volume scale only; trademarks belong to their respective owners and imply no affiliation or endorsement.
Compiled from Trehalose Dihydrate (For Injection) product documentation (Sep 2026 edition); the downstream blockbuster list is for illustrating use scenarios only — trademarks belong to their respective owners.
Document version: 2026-09 · CoA and inter-batch consistency data provided · on-site audits supported