Mannitol

    • Product Name: Mannitol
    • Chemical Name (IUPAC): hexane-1,2,3,4,5,6-hexol
    • CAS No.: 69-65-8
    • Chemical Formula: C6H14O6
    • Form/Physical State: Crystalline powder
    • Factroy Site: Lingwu, Yinchuan, Ningxia, China
    • Price Inquiry: sales2@liwei-chem.com
    • Manufacturer: Anhui Liwei Chemical Co.,Limited
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    Specifications

    HS Code

    742318

    Name Mannitol
    Chemical Formula C6H14O6
    Molar Mass 182.17 g/mol
    Appearance White crystalline powder
    Solubility In Water 216 g/L (25°C)
    Melting Point 165-169°C
    Pharmacological Class Osmotic diuretic
    Route Of Administration Intravenous
    Primary Use Reduction of intracranial and intraocular pressure
    Storage Conditions Store at room temperature, 20-25°C
    Cas Number 69-65-8
    Taste Sweet

    As an accredited Mannitol factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Mannitol is packaged in a sealed, white HDPE bottle containing 500 grams, labeled with product details, hazard information, and batch number.
    Container Loading (20′ FCL) Container Loading (20′ FCL) for Mannitol: Typically 16–18 metric tons, packed in 25 kg bags, on pallets or bulk, for safe transport.
    Shipping Mannitol is typically shipped in tightly sealed, moisture-resistant containers to preserve quality. It is classified as a non-hazardous, stable compound under normal shipping conditions. Ensure containers are labeled properly and protected from strong oxidizing agents. Store and ship in a cool, dry place, away from direct sunlight and incompatible materials.
    Storage Mannitol should be stored in a tightly closed container, protected from moisture and light. Keep it in a cool, dry, and well-ventilated area, away from incompatible substances. Avoid exposure to excessive heat and humidity. Store at room temperature, typically between 15°C and 30°C (59°F and 86°F). Ensure proper labeling and keep away from food and drink items.
    Shelf Life Mannitol typically has a shelf life of 3-5 years when stored in a tightly sealed container in a cool, dry place.
    Application of Mannitol

    Applications of Mannitol in Industrial Manufacturing

    Mannitol plays a critical role as a functional ingredient and formulation aid across multiple industrial sectors, where its unique physical and chemical characteristics support both product integrity and processing efficiency. Below we detail established end-use scenarios, aligning our manufacturing and quality systems with stringent regulatory demands and process requirements of leading downstream partners.

    1. Pharmaceutical Tablet and Capsule Manufacturing

    In pharmaceutical solid dosage forms, this polyol acts as a premium direct compression excipient, supporting tablet hardness, disintegration, and moisture protection, especially in chewable and orally disintegrating formulations. Our material meets strict impurity thresholds and particulate standards for oral dosage production, supporting high-speed direct compression and wet granulation lines. Manufacturers use mannitol to achieve uniform active ingredient distribution and pleasant mouthfeel, crucial for pediatric and geriatric medicines.

    Industry compliance standards

    • Current Good Manufacturing Practice (cGMP, 21 CFR 210/211)
    • United States Pharmacopeia (USP-NF) monograph for Mannitol
    • European Pharmacopoeia (Ph. Eur.) monograph 0431
    • International Conference on Harmonisation (ICH) Q6A guidelines

    Typical usage ratio

    • Direct compression: 10-50% of formulation weight, determined by active ingredient load, tablet size, and desired mouthfeel characteristics
    • Wet/dry granulation: 5-25%, adjusted for flowability and compressibility

    Downstream process integration

    • Added during primary blending phase with APIs and other excipients, or as a binder/carrier in the granulation stage; directly fed into tablet presses or encapsulation machinery

    Final product types

    • Chewable tablets
    • Orally disintegrating tablets (ODTs)
    • Capsules (filler/diluent)
    • Sublingual and effervescent tablets

    2. Injectable Medical Solutions

    In the field of parenteral preparations, this polyol functions as an osmotic diuretic agent and a solubilizer, incorporated during aseptic manufacture of intravenous solutions and lyophilized injectables. It provides required osmolality, ensures physiological compatibility, and acts as a stabilizer for temperature-sensitive actives throughout freeze-drying, filtration, and filling operations, particularly in hospital and emergency medicine sectors.

    Industry compliance standards

    • USP and Ph. Eur. Injectable Grade monographs
    • FDA 21 CFR 610.15 (Injectable product substances)
    • WHO Good Manufacturing Practices for Sterile Pharmaceutical Products (TRS 986, Annex 2)
    • Guidelines for Sterility Assurance and Endotoxin Testing (USP <71>, <85>)

    Typical usage ratio

    • For osmotherapy: 5–25% solution, specific to clinical indication and intravenous fluid balance requirements
    • As lyoprotectant: 2–15% in freeze-dried injectables, subject to protein or peptide drug stabilization needs

    Downstream process integration

    • Dissolved directly into water for injection during solution preparation; filtered before terminal sterilization or filling into glass ampoules, vials, or infusion bags; included as a stabilizing excipient in lyophilization cycles

    Final product types

    • Intravenous infusion solutions (osmotic diuretics, renal therapy)
    • IVD reagent kits (stabilizer component)
    • Lyophilized biologic drugs (injection vials)
    • Contrast media preparation

    3. Sugar-Free Confectionery and Chewing Gum

    Our customers in confectionery manufacturing utilize this ingredient as a bulk sweetener and texturizer, enabling low-calorie, sugar-free products that maintain desirable texture and pleasant cooling taste profiles. Its low glycemic index and resistance to Maillard browning suit sensitive flavor and color systems. Controlled particle size and flow support high-speed tableting, panning, and coating processes—minimizing dust and unplanned agglomeration on industrial lines.

    Industry compliance standards

    • Codex Alimentarius (INS 421, Food Additive Standard)
    • FDA GRAS Status (21 CFR 184.1601, Mannitol)
    • EU Regulation (EC) No 1333/2008 (Approved food additive E421 in permitted categories)
    • HACCP and Food Safety Management System (ISO 22000, FSSC 22000)

    Typical usage ratio

    • Chewing gum: 10-40% of base, optimized for shelf stability and chewability
    • Hard/pressed candies: 30-95%, depending on desired caloric content and biting texture

    Downstream process integration

    • Added after melting and mixing with other polyols, flavors, and colors; used in tableting presses, extruders, or as panning/coating medium in dragee and sugar-free candy lines

    Final product types

    • Sugar-free chewing gum pellets
    • Mints, compressed candies, dragees
    • Baking decoration pearls, low-calorie lozenges
    • Mouth-cooling powder sweeteners

    4. Food Processing: Bakery and Special Diet Products

    Within bakery and special dietary industries, this material enables the production of reduced-sugar, low-moisture, and diabetic-friendly goods. With high thermal stability and negligible water absorption, it supports extended shelf life and consistent crumb texture in high-output bakery environments. It withstands proofing and baking without caramelization, maintaining food safety and product integrity in allergen-free and keto product lines.

    Industry compliance standards

    • FDA GRAS Notification (GRN No. 41, 184.1601)
    • EU Regulation (EC) No 1169/2011 (Nutrition and labeling for sugar alcohols)
    • Global Food Safety Initiative (GFSI)-benchmarked schemes (BRCGS, IFS, SQF)
    • Halal, Kosher, and non-GMO status certificates (as requested per downstream customer audit)

    Typical usage ratio

    • Bakery: 2-12% of dry ingredients in sponge cakes, muffins, sandwich bread, or functional bars
    • Specialty applications may require 10-35% for sugar replacement in diabetic or ketogenic formulations

    Downstream process integration

    • Mixed into dry blends with flour, leavening agents, and other polyols during pre-mix/pre-dough phases; incorporated into mixers and dough sheeters prior to proofing and extrusion; sustains performance through high-temperature baking and cooling

    Final product types

    • Low-sugar sandwich bread, rolls, cakes
    • Nutrition and protein bars
    • Gluten-free and diabetic biscuits
    • Keto-friendly snacks and ready-to-eat baked goods

    5. Industrial Fermentation Processes

    Industrial processors rely on mannitol as a selective carbon source in biotechnology and microbiology fermentation protocols, particularly for cultivating lactic acid bacteria and as an osmoprotectant in microbial production. Control over impurities and trace metal content guarantees predictable performance in starter media, specialty enzyme production, and diagnostics reagents manufacturing, driving lot-to-lot reproducibility in highly regulated environments.

    Industry compliance standards

    • ISO 13485:2016 (Medical Laboratory Quality Management Systems)
    • Clinical and Laboratory Standards Institute (CLSI) guidelines for culture media
    • European Pharmacopoeia 2.6.12 “Microbiological examination”
    • Food and Drug Administration (FDA) regulations for fermentation-derived additives and APIs

    Typical usage ratio

    • Fermentation media: 0.5-5% w/v, adjusted to strain-specific metabolic requirements and fermentation kinetics

    Downstream process integration

    • Dissolved in growth media or sterile solutions prior to inoculation, ensuring substrate consistency through batch and fed-batch culture cycles; filtered for cell culture or diagnostic kit component blending

    Final product types

    • Selective microbiological culture media (e.g., mannitol salt agar)
    • Lactic acid bacterial starter cultures
    • Industrial enzymes produced via microbial fermentation
    • Diagnostic kits for clinical labs

    6. Oral Healthcare Formulations

    Oral care producers select this ingredient for toothpaste, mouthwash, and pharmaceutical lozenges, where it acts both as a crystallization control agent and non-cariogenic bulking sweetener. Its capacity to inhibit moisture-induced clumping supports bulk powder stability, while the mild sweetness and cooling sensation enhance user experience without contributing to dental caries, a critical differentiator in products for sensitive populations.

    Industry compliance standards

    • ISO 13485:2016 (Medical Devices – Quality Management)
    • EU Regulation (EC) No 1223/2009 (Cosmetics Regulation, applicable to oral hygiene)
    • FDA 21 CFR 355 (Anticaries and oral care drug products)
    • ADA (American Dental Association) Seal Guidance (for ingredient safety)

    Typical usage ratio

    • Toothpaste: 20–40% of slurry weight, balancing consistency and flavor delivery
    • Lozenges and pastilles: 25–95%, depending on matrix and active ingredient incorporation

    Downstream process integration

    • Incorporated during the pre-mix phase with abrasive agents, binders, flavors, and humectants; supports consistent extrusion and forming; in lozenges, blended before final pressing or molding

    Final product types

    • Fluoridated and herbal toothpaste
    • Antibacterial and whitening mouthwashes
    • Breath-freshener lozenges
    • Children’s oral care tablets and chewables

    Free Quote

    Competitive Mannitol prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please contact us at +8615380400285 or mail to sales2@liwei-chem.com.

    We will respond to you as soon as possible.

    Tel: +8615380400285

    Email: sales2@liwei-chem.com

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    Certification & Compliance
    More Introduction

    Mannitol—Reliable Polyol Produced with Expertise and Consistency

    Our Perspective on Mannitol’s Role in Today’s Chemical Industry

    For decades, our manufacturing lines have been dedicated to meeting the needs of industries that count on polyols with performance they can measure and trust. Mannitol stands out in our product line as a prime example of straightforward chemistry delivering real-world results. It's a white, crystalline polyol we produce in high volumes, and over time, we've fine-tuned both our batch and continuous processes so the end user receives material with dependable purity and consistency. This hands-on manufacturing experience, combined with ongoing investment in filtration and drying, means every shipment meets or exceeds the strict standards the pharmaceutical, food, and industrial sectors set.

    Model and Specifications Gained Through Experience

    We supply mannitol in multiple grades to handle varied performance targets. Our experience has shown that the needs within pharmaceuticals differ sharply from those in confectionery or technical applications. As a manufacturer, we produce regular powder grades and several sieve fractions so formulators control texture and process flow. Our pharmaceutical grade, for instance, undergoes additional recrystallization and filtration to reach high purity levels often above 98.5 percent as confirmed by multiple independent lab tests. Moisture content is always kept low because we see how residual water impacts both tablet robustness and shelf stability. Over-the-counter and prescription drug makers trust our mannitol in excipient and direct compression grades; each batch is systematically checked for reducing sugars, heavy metals, and microbial content long before dispatch.

    Over the years, we have responded to the needs of food processors who prefer mannitol with a tailored particle profile. Granular versions have a firm demand among customers making sugar-free chewing gum or coatings, while powder grades excel in blends for reduced-calorie sweeteners and dusting agents. Our plants run on automated controls supported by experienced staff who oversee blending, packaging, and sizing, resulting in reliable product lots. Each lot is marked with traceability data—because every processor or compounder benefits from knowing the origin and full handling record of their material.

    Choosing Mannitol: Practical Benefits and Responsible Manufacturing

    Our team pays attention to the details that set mannitol apart from other sugar alcohols. This molecule doesn’t absorb much water from the air, preventing lumping and dust formation in storage bins. That trait limits caking and improves powder flow in both factory and finished form. Pharmaceutical buyers, for example, notice that their tablets press cleanly without sticking, thanks to mannitol’s crystalline structure and minimal hygroscopicity. Food manufacturers appreciate that mannitol supplies gentle sweetness—about half as sweet as sucrose—along with a cooling effect on the palate. Unlike other polyols, our mannitol won’t easily ferment in the digestive tract, bringing a lower risk of gastrointestinal side effects even at moderate levels.

    Because our operation makes mannitol starting from wheat or maize starch hydrolysate, we control traceability from field to finished product. We have invested in process monitoring to ensure that the hydrogenation step reaches target yield and impurity profile—this is where substandard practices at other sites sometimes lead to unwanted byproducts or batch variability. Through consistent process control, we've minimized formation of side products like sorbitol or isomalt, which can swap in unnoticed with imported grades. Our team routinely reviews analytical data and confirms batch homogeneity through in-line and off-line checks, maintaining product integrity for end use.

    Supporting Pharmaceutical Use: More than Just an Excipient

    We see how mannitol’s balance of stability, compressibility, and inertness supports modern pharmaceutical development. Throughout our years supplying this industry, several trends have pushed our product design and quality programs. In tablet manufacturing, mannitol’s non-cariogenic property and low hygroscopicity help it excel where sugar or sorbitol fall short. We have worked closely with formulation scientists who require direct compression grades—material with precise particle size and low friability, ensuring robust tablets and minimal friable fines. During manufacturing technical visits, our specialists have helped customers adapt mannitol to high-speed tableting, substituting for lactose or dextrose when moisture sensitivity or patient tolerability demand a switch.

    Formulators making orally disintegrating tablets and chewables know our mannitol delivers smooth mouthfeel and reduces off-notes from actives or flavors. With experience in both the lab and production floor, we know excipient purity isn’t just about numbers—it’s about how batches behave in practice, maintaining low endotoxin counts after intensive washing and drying. We have also developed microfine grades for specialized applications like lyophilized injections, where mannitol acts as both bulking agent and cryoprotectant. Technical teams from our plant can help customers select from our grades, adjusting parameters like particle distribution and surface area based on tablet or powder preparation needs.

    Food Applications: Texture, Taste, and Shelf-Life Driven by Consistent Inputs

    Bakeries, confectionery makers, and specialty food processors frequently turn to our mannitol for more than just sweetness. Our crystalline grades supply a clean, cool finish and a pleasant interaction with gums, coatings, and chocolates. Through hands-on trials, we confirm that granulated mannitol resists melting and graining under elevated process temperatures, avoiding stickiness that often mars production with standard xylitol or sorbitol. Product stability on shelves rises because mannitol doesn’t absorb atmospheric moisture the way some other polyols do—meaning coatings stay glossy and powder blends avoid clumping.

    We recognize the pressure on food producers to offer low-calorie or diabetic-friendly items without off-flavors or strange aftertastes. Our team supports this with grades that avoid bitterness and deliver mouthfeel similar to traditional sugar. When working with frozen desserts, our customers see a reduction in ice crystal size due to mannitol’s lower solubility and cooling properties, improving creaminess without raising glycemic impact. Our experience with filling and packaging lines shows that mannitol’s lower reactivity and higher melting point stop it from “bleeding out” or caramelizing early, addressing real pain points in the industry.

    Industrial Uses: Reliable Polyol Chemistry and Consistent Processing

    For those manufacturing industrial or specialty chemicals, mannitol steps in as a reductant, chelating agent, or precursor to modern surfactants. Our operation focuses on producing uniform batches so end users can count on reactivity and purity—not a shifting target from one drum to the next. Chlor-alkali makers and resin syntheses need repeatable results; our filtration and packaging systems produce mannitol with low ash, predictable reducing end content, and a uniform melt profile.

    Over years of fielding technical calls, we have learned that impurities in mannitol—such as free sugars or colored components—can disrupt reactions or introduce byproducts that complicate downstream processes. Because we manage raw material sourcing and control hydrogenation conditions closely, downstream engineers tell us our batches behave predictably, offering the reproducibility they count on for yield improvements and waste reduction.

    Differences from Other Polyols: Direct Observations from Operations

    We routinely compare our mannitol against sorbitol, xylitol, and lactitol, since customers ask about substituting or blending polyols to balance cost and functional properties. Based on our own plant trials, mannitol beats sorbitol in long-term caking resistance. In press trials, mannitol’s compact crystal structure gives smoother mouthfeel and greater mechanical strength in tablets than xylitol-based blends. We hear from customers who’ve tried using lactitol or erythritol for dusting or tableting, only to switch to mannitol because our grades run cleaner on their equipment under humid summer conditions.

    In the lab, mannitol’s lower glycemic index and resistance to fermentation by oral bacteria help explain why it wins out in both dental care products and diabetic-friendly snacks. Our technical support team has demonstrated to food scientists that formulations using mannitol instead of isomalt require fewer stabilizers or anti-caking agents, simplifying ingredient lists and regulatory filings. For the resin and coatings industries, our mannitol brings a unique backbone structure, supporting more complex downstream chemistries with a lower risk of introducing unwanted impurities.

    Troubleshooting and Continuous Improvement: Listening to Users Makes a Better Product

    We value feedback from clients as much as we respect lab data. From watching mannitol run on high-speed presses to following up on complaints about caking, we've learned practical fixes and preventive steps. If a customer encounters tablets that chip too easily, our process engineers check friability with the customer, sometimes recommending a different batch or grade with verified compression data. In confectionery, clients struggling with dusting can request a sieved grade, and we follow up to ensure process improvements stick.

    Our plant operators run regular audits to catch pitfalls before they reach the customer—residual process solvents, bacterial counts, or packaging damage get flagged in-house. Field staff provide technical troubleshooting, not just sales talk, so users understand which grade will fit their process. Over time, this feedback loop reduces waste, cuts hold-ups, and strengthens both our product and customer trust. Our experience teaches us mannitol’s best performance emerges hand in hand with practical, transparent communication—not just certificates and paperwork.

    Traceability and Compliance: From Raw Material to Finished Product

    Factories live or die on traceability. We maintain full traceability records on our mannitol, from corn or wheat input through hydrolysis, hydrogenation, filtration, drying, and packing. Inspection and release records allow our customers to audit supply chains—knowing what lands in their hands meets the purity and regulatory requirements for food and drug use. Our plant has hosted site visits from both regulatory authorities and manufacturing partners; observing our allergen controls, non-GMO sourcing, and proactive quality checks helps build mutual trust.

    Our compliance team keeps pace with evolving pharmacopeial and food standards, updating analytical methods to maintain alignment. Ingredients for regulated industries like drugs or infant nutrition pass extra microbiological and heavy metal screens, reflecting real risks in today’s global supply network. We have supported customers through voluntary and mandatory recalls by supplying detailed batch histories; thanks to strong traceability, issues are quickly isolated and corrective action applied. Our in-house documentation process limits downtime and keeps customers’ records audit-ready.

    Reducing Environmental Footprint: Smarter Resource Use and Closed-Loop Systems

    Making polyols such as mannitol demands both energy and water. Our factory runs recovery systems to cut down on waste and recapture process solvents and condensate water, helping us dial back both costs and emissions. Waste starch hydrolysate is recycled in feed chain supply, and we keep track of process byproducts, diverting them for use in animal feed or biogas. For reagent inputs, our buying contracts encourage local, responsible farming, and our pretreatment stage cuts down on residual pesticide or herbicide carryover. Conservation isn’t just a slogan here: year over year, our numbers show reductions in energy use per ton of material shipped. Each metric ton of mannitol that leaves our warehouse carries a smaller footprint because process changes respond to both cost and stewardship.

    Customers in Europe and Asia purchase mannitol partly for its reputation as a clean-label ingredient. Our documentation supports both non-GMO and allergen-free claims, which are grounded in careful sourcing and strict lot segregation. We submit to third-party environmental audits and remain transparent about our resource flows, aiming for not just compliance but real environmental impact reduction.

    Moving Forward: Fine-Tuning for a Changing Marketplace

    Demand for mannitol rises as food, pharmaceutical, and technical producers seek to substitute cane sugar and high-calorie sweeteners. Our team, from lab chemists to shift supervisors, reviews manufacturing data to enhance batch-to-batch consistency and push yields higher. Each year’s capital spending is partly driven by customer input—new filtering technologies or updated process controls grow from requests for higher purity or different particle size.

    We track regulatory changes and scientific developments in stabilizers, tableting aids, and food safety to keep our mannitol aligned with industry needs. Our veterinarian and medical device customers have prompted us to expand analytical testing, watching out for nitrosamines and other potential contaminants. By keeping the manufacturing process both visible and responsive to market input, we ensure users benefit from experience, not just commodity pricing.

    Why Choosing a Manufacturer Matters

    Purchase decisions driven only by price often overlook long-term process problems—batch inconsistency, stiffness or stickiness, shelf life claims failing in market. Working directly with a manufacturer brings advantages; users can influence lot specifications, access detailed feedback, and troubleshoot with people who understand root process chemistry. Our team stands behind every lot; defects get immediate attention, continuous improvements reflect industry realities.

    Mannitol remains a staple in our product line because it consistently solves formulating, processing, and storage challenges across a range of industries. Our customers count on us for more than just material—they benefit from an open channel to the engineers and operations staff who make the product. Choosing mannitol directly from the source ensures the support, reliability, and traceability every manufacturer wishes for when product quality and compliance are on the line.