Mitigating Risks: The Strategic Selection of Solvent-Free Saccharide Excipients
July 6, 2026
With growing concerns about residual solvents and FDA guidance on benzene contamination, pharmaceutical manufacturers must ensure every batch meets strict safety standards. As a solution provider, the NAGASE Group supports pharmaceutical manufacturers by offering solvent‑free, ethanol‑free excipients from Nagase Viita that are based on enzyme‑driven technology. This approach eliminates the variability, repeated assessments, and compliance risks associated with organic‑solvent use. By reducing regulatory uncertainty and operational burden, we enable faster development cycles and help deliver formulations that achieve a high level of patient safety.
Key Features of Saccharide Excipients from Nagase Viita
100% Water-Based, Enzyme-Driven Production
Leveraging over a century of biotechnology expertise, Nagase Viita has replaced traditional chemical synthesis and ethanol precipitation with advanced enzymatic reactions.
Zero ICH Q3C Solvents
No Class 1, 2, or 3 solvents are used at any stage of Nagase Viita’s manufacturing—from raw material procurement to final purification.
Redefining Excipient Excellence through Enzymatic Engineering
Nagase Viita is at the forefront of this industrial transition, offering a high-purity portfolio of saccharide excipients manufactured through the proprietary "Pure-Stream" process. The process utilizes specific enzymes (e.g., Isoamylase, MTSase and MTHase) to produce high-purity saccharides entirely within a water-based environment.
This "Pure-Stream" approach ensures consistent, pharmaceutical-grade quality for the most demanding applications, including biologics and injectables.
Empowering Formulations with Solvent-Free Excellence
The NAGASE Group offers a comprehensive range of saccharide excipients, all manufactured through Nagase Viita’s proprietary, enzyme-driven Pure-Stream process. This solvent-free manufacturing ensures the highest levels of safety and compliance across all drug modalities.
Parenteral Excipient (SOLBIOTE™) (Manufacturer: Nagase Viita Co., Ltd.)
| Product Name | Chemical Name | Purity/Other | Application | Regulatory Approval/Others |
|---|---|---|---|---|
| TREHALOSE SG | Trehalose Dihydrate |
99.0%~101.0% /Low Endotoxin |
・Stabilization of antibodies, peptides, and vaccines for injection ・Additive for culture medium |
JP/USP-NF/Ph. Eur./CP/ Kosher, Halal |
| MALTOSE PH | Maltose Hydrate |
Not less than 98.0% /Low Endotoxin |
・ Stabilizer of immunoglobulins ・ Solubility enhancer stabilizer of APIs |
JP/CP/Kosher, Halal |
| SUCROSE SG | Sucrose |
Not less than 98.0% /Low Endotoxin |
・LNP stabilization | JP/USP-NF/Ph. Eur./ Kosher, Halal |
Oral Excipient
| Product Name | Chemical Name | Purity/Other | Application | Regulatory Approval/Others |
|---|---|---|---|---|
| TREHALOSE 100PH | Trehalose Dihydrate | 99.0%~101.0% |
・ Additive for oral solutions (Ex: stabilizer, taste improver, solubility enhancer for minerals) ・ Excipient for solid oral dosage forms (Ex: Tablets) |
JP/USP-NF/Ph. Eur./ Kosher, Halal |
| PULLULAN | PULLULAN | - |
・Additive for solid oral dosage forms (Ex: Binder, Tablet coating, Granulation) ・Film |
JP/USP-NF/Ph. Eur./ Kosher, Halal |
| SUNMALT™-S | Maltose Hydrate | Not less than 92.0% | ・Excipient for solid oral dosage forms (Ex: Tablets, Granules) | USP-NF/Kosher, Halal |
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