Isomalt (CAS: 64519-82-0) is a functional bulk sweetener produced through enzymatic transglucosylation of sugar beet sucrose followed by catalytic hydrogenation, resulting in an equimolar composition of alpha-D-glucopyranosyl-1,6-mannitol (1,6-GPS) and alpha-D-glucopyranosyl-1,6-sorbitol (1,6-GPM) with a clean sweetness profile, low glycemic impact, and high stability for advanced food and pharmaceutical manufacturing.
Key Specifications
|
Parameter |
Limit / Specification |
Test Method |
|
Stereoisomer Ratio |
1:1 molar ratio (1,6-GPS : 1,6-GPM) |
HPLC |
|
Assay (Dry Basis) |
≥ 98.0% |
HPLC |
|
Moisture (Powder) |
≤ 1.0% |
Karl Fischer |
|
Moisture (Granular) |
≤ 0.3% |
Karl Fischer |
|
Reducing Sugars |
≤ 0.3% |
Titrimetry |
|
Heavy Metals (as Pb) |
≤ 0.5 mg/kg |
ICP-MS |
|
Nickel Residue |
≤ 1.0 mg/kg |
ICP-MS |
|
Sulfated Ash |
≤ 0.1% |
Gravimetric |
Grade Standards & Customization
FCC Food Grade: Conforms to Food Chemicals Codex specifications, optimized for direct compression confectionery and panning.
USP/EP Pharmaceutical Grade: Complies with United States and European Pharmacopoeia monographs for oral solid excipient applications.
Granulation Customization: Available from fine micronized powder (≤ 200 mesh) to coarse granules (10–40 mesh), tailored for specific bulk density and flowability targets.
Functional Properties
Low Hygroscopicity: Absorbs under 2% moisture at 25°C and 70% relative humidity, ensuring long-term anti-caking performance.
Thermal & Acid Resistance: Endures temperatures up to 200°C without caramelization and resists inversion in low-pH environments.
Metabolic Inertness: Exhibits a glycemic index of 2 and negligible insulinemic response for diabetic-friendly formulations.
Dental Protection: Non-cariogenic profile prevents oral plaque fermentation and enamel demineralization.
Clean Mouthfeel: Neutral flavor delivery without bitter aftertastes or intense cooling sensations.
Manufacturing & Technical Control
Continuous Hydrogenation: Advanced catalytic reactors combined with multi-stage ion-exchange purification ensure ultra-low trace metal profiles.
Crystallization Kinetics: Tightly regulated 1,6-GPS to 1,6-GPM molecular ratios deliver batch-to-batch melting point consistency.
Fluid-Bed Agglomeration: Engineered spherical particle morphology maximizes tablet hardness and mechanical strength during high-speed compression.
Target Applications
Sugar-Free Confectionery: Primary structural matrix for drop-poured hard candies, lollipops, and lozenges.
Oral Solid Dosage: Direct-compression diluent and binder for chewable tablets, vitamins, and active pharmaceutical ingredient masking.
Coating Systems: Functional shell agent for hard-panned dragées and chewing gum center applications.
Nutraceutical Matrices: Texturizing bulking agent for dietary supplement bars and functional powders.
Quality Assurance & Testing Protocols
Chromatographic Assay: High-Performance Liquid Chromatography validation for precise disaccharide and reducing sugar quantification.
Thermal Characterization: Differential Scanning Calorimetry monitoring glass transition and melting transitions.
Microbial Safety: Total aerobic plate count, yeast, mold, and pathogen screening per harmonized pharmacopeia requirements.
Regulatory Documentation & Compliance
Batch Dossiers: Complete provision of Certificate of Analysis, Technical Data Sheet, and Safety Data Sheet per shipment.
Facility Certifications: Manufactured under ISO 9001, FSSC 22000, Kosher, and Halal accredited management systems.
Supply Chain Declarations: Verified Non-GMO, allergen-free, BSE/TSE-free, and residual solvent status compliance.
Storage Requirements
Ambient Control: Store in temperature-controlled environments below 25°C and relative humidity under 65%.
Sealed Integrity: Retain in original multi-ply paper bags or polyethylene-lined fiber drums to prevent atmospheric moisture exposure.
Shelf Life: Guaranteed stability for 36 months under recommended containment conditions.
Packaging & Logistics Specifications
Standard Units: 25 kg multi-ply paper bags featuring moisture-barrier PE inner liners; 1,000 kg industrial FIBC jumbo bags available.
Minimum Order Quantity (MOQ): 1 Metric Ton (Flexible for initial sample trials and custom trial orders).
Palletization: Secured on fumigation-free wooden or plastic pallets wrapped with UV-resistant stretch film.
Intermodal Shipping: Containerized 20-foot and 40-foot dry van configurations optimized for secure transit.
Frequently Asked Questions
Q: What is the typical melting range of the product?
A: The melting range spans between 145°C and 150°C, depending on the specific ratio of crystalline hydrates and anhydrous fractions.
Q: Are anti-caking agents required during extended warehouse storage?
A: No anti-caking additives are required due to the material's inherently low hygroscopicity under standard warehouse conditions.
Q: How does sweetness compare to standard sucrose?
A: It provides 45% to 60% of the sweetness of sucrose, allowing blends with high-intensity sweeteners to match exact sucrose profiles.
Q: Can particle size distribution be adjusted for specialized tablet presses?
A: Yes, mechanical milling and air-classification parameters are fully adjustable to meet custom direct-compression particle size curves.
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