Sorbitol is a high-purity polyol synthesized via the controlled catalytic hydrogenation of D-glucose, serving as an essential bulk sweetener, humectant, and texturizing agent in regulated industrial formulations. Available in free-flowing crystalline powder and stable aqueous liquid solutions, it delivers controlled sweetness and moisture retention without contributing to dental caries. Manufactured under rigorous quality management systems, each batch ensures predictable performance and reliable downstream processing compatibility for global formulators.
Key Specifications
|
Parameter |
Crystalline Grade |
Liquid Grade |
|
Assay (D-Sorbitol) |
99.0% min. (dry basis) |
70.0% min. |
|
Reducing Sugars |
0.05% max. |
0.05% max. |
|
Moisture Content |
1.0% max. |
N/A |
|
Heavy Metals (as Pb) |
10 ppm max. |
10 ppm max. |
|
Residue on Ignition |
0.1% max. |
0.1% max. |
Compliance & Quality Standards
Pharmacopeial Monograph: Conforms to USP, BP, and EP specifications for pharmaceutical excipients and direct compression.
Food Chemical Codex: Complies with FCC standards for food and beverage additive safety.
Dietary & Allergen Status: Non-GMO, allergen-free, Kosher, and Halal certified for worldwide distribution.
Functional Properties
Moisture Retention & Plasticizing: Regulates water activity effectively to prevent desiccation, hardening, and crystallization over extended shelf lives.
Thermal Stability: Withstands high processing temperatures during extrusion and baking without caramelization or degradation.
Non-Cariogenic Profile: Resisted by oral micro-organisms, preventing plaque formation in oral care and confectionery products.
Solution Rheology: Exhibits low ambient viscosity, allowing seamless pumping and uniform mixing in liquid systems.
Technical Focus & Manufacturing Control
Particle Size Distribution: Crystalline grades maintain strict mesh sizing (100% passing through 40 mesh) to ensure optimal powder flowability.
Hydrogenation Precision: Advanced reactor monitoring eliminates residual nickel catalysts and restricts anhydrosorbitol by-products.
Microbial Safeguards: Total aerobic microbial counts are restricted below 100 CFU/g via sterile filtration and controlled drying.
Pyrogen Control: Pharmaceutical grades undergo strict depyrogenation validation for high-safety oral and injectable-adjacent solutions.
Target Applications
Confectionery: Acts as a cooling-effect bulking agent in sugar-free chewing gums and hard candies.
Pharmaceuticals: Functions as a crystallization inhibitor and viscosity modifier in syrups, elixirs, and direct-compression tablets.
Nutraceuticals: Serves as a primary carrier and chewable binder in vitamin and mineral tablets.
Baked Goods: Retains moisture in nutrition bars and soft fillings, preventing staling during storage.
Quality Control & Testing
Chromatographic Assay: High-Performance Liquid Chromatography (HPLC) quantifies isomer purity and trace impurities per lot.
Trace Metal Screening: Inductively Coupled Plasma Mass Spectrometry (ICP-MS) tests raw inputs and finished goods.
Inline Moisture Sensing: Near-Infrared (NIR) sensors monitor drying chambers continuously to enforce strict water tolerances.
Microbiological Verification: Plate counts and selective media testing verify pathogen absence prior to release.
Documentation & Compliance Support
Lot-Specific COA: Shipments include certificates detailing exact assay, moisture, and impurity metrics.
Regulatory Dossiers: Full technical data packages include BSE/TSE statements and residual solvent declarations.
Traceability Records: Complete forward and backward lot tracking maintained for a minimum of five years.
Change Control Commitment: Formal advance notification issued for any alterations in raw materials or processing.
Storage Guidelines
Temperature Control: Store in sealed containers between 15°C and 30°C away from direct thermal sources.
Humidity Management: Keep crystalline powder in relative humidity below 60% to eliminate caking risks.
Liquid Maintenance: Maintain liquid solutions above 20°C with heated storage tanks for bulk handling.
Packaging & Logistics
Crystalline Packaging: 25 kg multi-layer paper bags with food-grade polyethylene inner liners on fumigation-free pallets.
Liquid Packaging: 250 kg HDPE drums or 1,000 kg Intermediate Bulk Containers (IBC) with tamper-evident seals.
Transit Protection: Moisture-absorbent desiccants placed inside shipping containers to prevent condensation during ocean freight.
Frequently Asked Questions
Q: What differentiates crystalline and liquid sorbitol in tableting?
A: Crystalline powder suits direct compression and dry granulation, while liquid acts as a plasticizer in wet granulation and syrup vehicles.
Q: Does the manufacturing process generate polyol degradation by-products?
A: No. Strict reaction monitoring limits anhydrosorbitol and reducing sugars to minimal thresholds, ensuring stability in reactive formulas.
Q: How is caking prevented during international maritime shipping?
A: Low-moisture processing, barrier liners, and container desiccants are deployed to eliminate transit caking risks.
Q: Are analytical methods validated to compendial standards?
A: Yes. All internal testing procedures follow validated USP and EP protocols, with method transfer data available upon request.
Q: What is the certified shelf life under standard storage conditions?
A: Crystalline powder remains stable for 24 months, and liquid solution remains stable for 12 months in unopened original containers.
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