Mannitol (E421)

Description

1. Product Overview
   Mannitol (E421) is a crystalline sugar alcohol used as a functional excipient and processing aid across pharmaceutical, food, and specialty chemical industries. Its primary industrial uses include tablet and capsule formulation, low-hygroscopic bulking agent in food processing, and osmotic diuretic applications in downstream chemical synthesis. Mannitol offers stable physical properties, low hygroscopicity, and predictable compaction behavior—delivering formulation robustness, extended shelf stability, and consistent process yields. Strategically, Mannitol is a high-value commodity excipient essential to quality-sensitive manufacturing lines where regulatory compliance, batch-to-batch consistency, and supply continuity directly affect product performance and market access.

2. Key Specifications & Technical Characteristics

• Chemical name: D-Mannitol (1,2,3,4,5,6-hexanehexol)

• CAS number: 69-65-8

• Composition: Pure mannitol (no added binders or carriers)

• Grade: Food and Pharmaceutical grade (E421), complies with major pharmacopeias where specified (buyer to confirm required monograph)

• Purity: Typical ≥ 99.5% (assay by HPLC); specification-adjustable per contract

• Appearance: White to off-white crystalline powder or granules

• Particle size: Available in multiple distributions — powder (<100 µm), fine crystal (100–300 µm), and coarse granules (300–1000 µm); custom milling on request

• Bulk density: Typical range 0.4–0.7 g/cm³ (tapped and loose density variants supplied on request)

• Moisture content: Typically ≤ 0.5% w/w (controlled for low-hygroscopic applications)

• Solubility: Freely soluble in water; insoluble in non-polar solvents

• pH (1% aqueous): Approximately neutral (around 6.5–7.5)

• Microbiology: Total viable count and absence of objectionable organisms available on Certificate of Analysis (CoA)

• Heavy metals and residual solvents: Compliant with regulatory limits; CoA provided

• Packaging options: 25 kg double-layer kraft bags with PE liner; 500 kg and 1,000 kg FIBCs (big bags); bulk tanker/shuttle delivery for slurry or liquid formulations (by prior arrangement)

• Shelf life: 24 months when stored in original sealed packaging, in a cool, dry place away from direct sunlight and strong oxidizers

3. Core Industrial Applications

• Pharmaceuticals: Direct compression excipient for tablets, tablet diluent, chewable formulations, and capsules — chosen for low hygroscopicity, excellent mouthfeel, and predictable compaction that reduce rejection rates and improve downstream coating performance.

• Food & Confectionery: Low-calorie sweetening agent, bulking agent for sugar-free and reduced-calorie products, freeze-drying protectant for specialty foods — provides stability in storage and processing with minimal moisture uptake.

• Chemical & Bioprocessing: Cryoprotectant and osmotic agent in bioprocess formulations, reagent in specialty chemical syntheses where a non-reducing sugar alcohol is required — valued for chemical inertness and predictable solubility.

• Medical Devices & Diagnostics: Component in calibration standards, osmolality controls, and stabilizers for certain diagnostic reagents — offers regulatory familiarity and consistent analytical behavior.
  Why it outperforms alternatives:

• Lower hygroscopicity than many polyols, reducing caking and process variability.

• Superior compressibility versus sugar-based diluents, enabling higher throughput and fewer weight/strength failures.

• Neutral taste and chemical inertness reduce formulation interactions and simplify regulatory filings.

• Available particle-size tailoring reduces process development time and improves line yield.

4. Competitive Advantages

• Quality consistency: Manufactured to controlled specifications with batch CoA, in-process controls, and traceability from raw material to finished goods.

• Supply reliability: Robust sourcing and buffer stock policies designed to support continuous production for enterprise customers; scalable production to meet large contracts.

• Logistics capability: Flexible packaging (small bags to bulk FIBC and tanker options), container loading expertise, and export documentation support for global trade lanes.

• Price competitiveness: Tiered pricing for volume contracts and long-term agreements; cost-of-goods optimized for B2B procurement while maintaining quality margins.

• Sustainability: Production processes optimized for energy efficiency and waste minimization; options for sustainable sourcing and documentation available upon request.

• Technical support & documentation: Comprehensive technical datasheets, CoA, SDS, and regulatory support documentation available; application support for formulation optimization and particle-size recommendations.

5. Commercial & Supply Information

• Minimum order quantity (MOQ): BULK 20 MT

• Loading capacity (MT per container):

  • 20-foot container (FCL): up to 20 MT in 1,000 kg FIBCs (subject to payload limits and packaging configuration)

  • 40-foot High Cube (HC): up to 24–26 MT in 1,000 kg FIBCs (subject to packaging and shipping regulations)

• Lead times: Subject to order size and contract terms; standard lead-time and expedited options available on request

• Terms: Pricing and delivery terms subject to Incoterms; export documentation, CoA, SDS, and packing lists provided with shipments