Mannitol
Mannitol is what formulators reach for when lactose is ruled out. It is non-reducing, so it will not brown against an amine active; it is essentially non-hygroscopic, so it protects moisture-sensitive drugs; and it dissolves with a distinct cooling sweetness that makes chewable tablets palatable.
Chelora Chemicals supplies mannitol to pharmaceutical, nutraceutical and food manufacturers worldwide, in powder, granular, direct-compression and parenteral grades, with a batch COA, GHS safety data sheet and the regulatory statements your QA file needs.
Product identity
- CAS Number
- 69-65-8
- Compendial name
- Mannitol / Mannitolum
- Molecular formula
- C₆H₁₄O₆
- Molecular weight
- 182.17 g/mol
- EC / EINECS
- 200-711-8
- Food additive number
- E421
- Pharmacopoeias
- USP-NF · Ph. Eur. · JP · IP · BP
- HS Code
- 2905 43*
* Confirm the exact HS heading with your customs broker — polyhydric alcohols can sit under a different subheading depending on the destination tariff schedule and the declared end use.
What Mannitol is used for
Mannitol is a white, odourless, free-flowing crystalline powder — a six-carbon sugar alcohol produced by catalytic hydrogenation of a sugar feedstock. Because the aldehyde group has been reduced away, it is non-reducing: the single property that most distinguishes it from lactose and that decides a great many formulation choices.
In solid dosage work it fills chewable tablets and orally disintegrating tablets, where its cooling sweetness is as much the point as its bulk. In sterile manufacture it is the standard bulking agent for freeze-dried products, crystallising cleanly to give an elegant, mechanically sound cake. It is also used as a parenteral osmotic agent and as a bulk sweetener in sugar-free confectionery under E421.
Where it sits among fillers and polyols
- Mannitol (this product) non-hygroscopic, non-reducing, strongly cooling; the premium filler of the group.
- Sorbitol the isomer; cheaper but distinctly hygroscopic, which rules it out of many tablet formulations.
- Xylitol sweeter and more strongly cooling still, used mainly in confectionery and oral care.
- Lactose monohydrate cheaper and the industry default, but reducing and therefore amine-incompatible. See that page.
The choice between mannitol and lactose usually comes down to the active, not the price — see the full excipient range.
Appearance and handling character
The material is freely soluble in water, stable, and almost indifferent to humidity — it takes up negligible moisture below about 90% relative humidity, which is why it stores and handles so easily. It is not classified as a hazardous substance. The practical considerations are its poor compressibility in standard crystalline form, and the trace nickel specification that follows from the hydrogenation route.
| Parameter | Typical value |
|---|---|
| Appearance | White crystalline powder or granules |
| Assay (dried basis) | 98.0 – 102.0% |
| Specific rotation | +23° to +25° |
| Loss on drying | 0.5% max |
| pH (10% solution) | 5.0 – 8.0 |
| Reducing sugars (as glucose) | 0.2% max |
| Related substances (sorbitol) | 2.0% max |
| Nickel | 1 ppm max |
| Residue on ignition | 0.1% max |
Important: the figures above are indicative of compendial-grade material and are offered for planning only. The batch certificate of analysis is the governing document. Grade and particle size are what most affect performance — tell us your application and we will quote against it.
| Grade | Character / typical use |
|---|---|
| Powder (fine) | Wet granulation · dusting |
| Granular | Good flow · capsule fill, dry blends |
| Spray-dried / DC grade | Direct compression · ODT |
| Parenteral grade | Low endotoxin · injectables, lyophilisation |
| Food grade | Sugar-free confectionery, chewing gum |
Parenteral grade is a distinct product with its own endotoxin and particulate specification, not a tableting grade with extra testing. Specify it explicitly where you need it.
Where our customers put this excipient to work
From chewable tablets to sterile freeze-dried vials — a wider span of dosage forms than most fillers cover.
Chewable tablets
The cooling sweetness and clean mouthfeel make mannitol the standard base for chewables, where taste is as much a specification as hardness.
- Granular or DC grades
- Negative heat of solution
- Blend trials supported
Orally disintegrating tablets
Dissolves rapidly and pleasantly in the mouth, which is exactly what an ODT needs from its filler.
- Spray-dried DC grades
- Pairs with croscarmellose sodium
- Formulation guidance available
Lyophilisation bulking agent
Crystallises cleanly during freeze drying to give a mechanically strong, elegant cake that reconstitutes quickly.
- Parenteral grade required
- Low endotoxin specification
- Technical desk review of your cycle
Moisture-sensitive actives
Essentially non-hygroscopic, so it protects hydrolytically unstable drugs far better than lactose or starch can.
- Stability-driven filler choice
- Works where lactose browns
- Full impurity profile on request
Parenteral osmotic agent
Used in injectable solutions as an osmotic agent, where the specification is driven by endotoxin and particulates rather than by flow.
- Parenteral grade only
- Endotoxin reported per batch
- Sterile-manufacture documentation
Sugar-free confectionery
A bulk sweetener under E421 and the traditional dusting powder for chewing gum, where its non-stickiness is the whole point.
- Food-grade specification available
- Halal, kosher and vegan statements
- Non-GMO declaration on request
How we supply Mannitol
Chelora Chemicals is a supplier and sourcing partner, not a manufacturer. On an excipient that spans tableting and sterile manufacture, owning no plant means we are never selling you a tableting grade for a parenteral job — we route your order to the producer qualified for the application you actually have.
We place your order with whichever qualified producer best matches your grade, your compendial requirement, your price point and your delivery window.
We keep a second qualified source on this line. Excipient changes are a regulatory event, so we would rather you qualify the alternate in advance than scramble when a plant goes down.
- Grade confirmed against the application before we quote. Parenteral, DC and standard powder grades are different products, and we establish which you need in the first reply.
- Nickel and related substances stated. Trace nickel follows from the hydrogenation route, and we report it rather than leaving you to ask.
- Compendial coverage confirmed first. USP-NF, Ph. Eur., JP or IP — we establish which monographs your filing cites before the quote, not after.
- Endotoxin data on parenteral grade. Where the material is going into an injectable, the bacterial endotoxin result comes with the COA as standard.
- Full regulatory statement pack. BSE/TSE, GMO, allergen, residual solvent, elemental impurity and nitrosamine risk statements with the consignment.
- Change notification taken seriously. If a source plant changes anything that touches your filing, you hear about it from us first.
Packed the way your plant receives it
Mannitol is easy to store and ship, which keeps the packing conversation simple — until the material is going into a sterile area. Tell us where it will be used and we will quote accordingly.
Multiwall paper bags
Kraft bags with an inner PE liner on shrink-wrapped pallets — the standard pharmaceutical format and the lowest cost per kilo.
Fibre drums, lined
Lined fibre drums where your store handles drums rather than bags, or for speciality and parenteral grades.
Double-bagged clean packing
Double polyethylene bagging suitable for transfer through an airlock into a controlled area, for injectable and lyophilisation use.
Jumbo bags (FIBC)
Lined, discharge-spout FIBCs for confectionery and high-volume nutraceutical users with bulk-bag handling.
Trial / sample quantities
Small packs dispatched so your formulation team can run compression or freeze-drying trials before committing to a grade.
Incoterms to suit you
Quoted on the Incoterm your purchasing team works to, with export documentation filed before the booking is made.
One of the easiest excipients in the warehouse
Mannitol is not classified as hazardous, is used as a food ingredient and as an injectable, and stores almost indifferently to humidity. The points worth attention are dust control and — if it is going into a sterile area — the handling discipline that comes with the destination rather than the material. The summary below is orientation only — the safety data sheet supplied with your consignment is the authoritative document.
Hazard position
GHSNot classified as a hazardous substance or mixture.DUSTNuisance dust; may cause mechanical irritation to eyes and the respiratory tract.ATEXCombustible organic dust — precautions apply in enclosed handling.LAXLaxative effect at high oral intake — a formulation and labelling consideration.
The laxative point matters at nutraceutical and confectionery dose levels rather than in a typical tablet, but it belongs in your labelling assessment where daily intake is substantial. Always read the SDS issued with your specific batch.
Practical handling notes
- Do not expect crystalline powder to compress. If tablets are soft, the answer is usually a DC grade rather than more pressure or more binder.
- Keep parenteral grade segregated. Once a bag of parenteral material has been into a general production area it should not go back into the sterile stream.
- Extract at tipping points. Nuisance dust at a bag tip is the commonest comfort complaint on this product.
- Mind the polymorph on freeze drying. Mannitol crystallises in more than one form, and the cycle conditions determine which one you get.
- Clean up by vacuum. It is soluble, so a wet clean works, but collecting dry first avoids a sticky residue.
Storage
- Cool, dry, well-ventilated store. Ordinary warehouse conditions; mannitol is among the least demanding excipients to store.
- Keep containers tightly closed. More to keep odours and contamination out than to keep moisture out.
- Segregate from strongly scented materials. Adsorbed odour carries into the finished dosage form, and it matters most in a chewable product.
- Keep off the floor and away from external walls. Standard GMP warehousing practice.
- Shelf life typically 36–60 months. In sealed original packing — longer than most excipients, reflecting how stable it is.
Handling & PPE
- Standard GMP powder handling. Local exhaust at tipping points, gloves, safety glasses and a dust mask where airborne powder is generated.
- Separate flows for parenteral grade. Dedicated handling and airlock transfer where the material is destined for sterile manufacture.
- Static control on transfer. Earthed equipment where the material is conveyed pneumatically.
- Dedicated scoops and containers. Cross-contamination control matters more here than personal protection.
- Dispose of as ordinary non-hazardous waste. Subject to your local waste classification.
Transport
Mannitol is not a regulated dangerous good and ships as general cargo by road, sea and air. We issue the commercial and compendial documentation with every consignment — ask us for the full document pack when you plan the shipment.
What travels with every consignment
On an excipient that can end up in an injectable, the documentation has to be right before the material is. We verify it rather than forwarding it.
Certificate of Analysis
Batch-specific assay, specific rotation, LOD, pH, reducing sugars, related substances and nickel against the monographs you cite.
GHS Safety Data Sheet
Full 16-section SDS in GHS format, issued in the language your destination requires, confirming the unclassified status in writing.
Endotoxin & microbial data
Bacterial endotoxin and microbial limit results reported per batch on parenteral grade, where they are the governing specification.
Elemental impurities & residual solvents
ICH Q3D elemental impurity data including nickel, plus residual solvent statements and a nitrosamine risk assessment where your filing needs one.
BSE/TSE, GMO, halal & kosher
Plant-derived with no animal material at any stage; certification and allergen statements supplied with the consignment.
Retained & pre-shipment samples
Pre-shipment samples carry the same COA as the commercial lot, so what your laboratory qualifies is exactly what arrives.
A sugar with the aldehyde taken off
Hydrogenating the carbonyl group is what turns a reactive reducing sugar into an inert, non-hygroscopic polyol. Every property that makes mannitol useful follows from that one change. The steps below are the general industrial pattern, not a process disclosure.
Start from a sugar feedstock
Glucose or fructose syrup, typically derived from starch, is purified and prepared for hydrogenation.
Hydrogenate catalytically
Hydrogen is added across the carbonyl group over a metal catalyst, giving a mixture of mannitol and sorbitol.
Separate the isomers
Mannitol is far less soluble than sorbitol, so fractional crystallisation separates the two cleanly.
Crystallise, dry and grade
Final crystallisation and drying set the polymorph and particle size; spray drying produces the direct-compression grades.
Why grade, polymorph and nickel all matter
Two bags can both meet the monograph exactly and behave quite differently in your process:
- Crystalline mannitol does not compress. It flows beautifully and compacts poorly, which is why the spray-dried DC grades exist and why substituting one for the other fails immediately.
- Polymorphic form matters in lyophilisation. The beta form is the commercial standard, but cycle conditions can produce others, and the cake's mechanical strength follows from which one crystallises.
- Nickel traces back to the catalyst. It is the characteristic residue of the hydrogenation route, limited by the pharmacopoeias and worth checking on a parenteral application.
- Sorbitol content is the key related substance. Its presence raises hygroscopicity, which undermines the main reason you chose mannitol.
That is why we confirm the grade against your application before quoting, and why the batch COA is shared for approval before dispatch rather than sent with the invoice.
| Material | Character / use |
|---|---|
| Mannitol CAS 69-65-8 — this product | Non-hygroscopic · non-reducing |
| Sorbitol CAS 50-70-4 | Isomer · hygroscopic |
| Xylitol CAS 87-99-0 | Sweeter · strong cooling |
| Lactose monohydrate CAS 64044-51-5 | Cheaper · reducing sugar |
We supply across the excipient range — see the full excipient range. Send your formulation and we will confirm the grades before quoting.
What actually moves the price of this product
Knowing what drives the quote helps you time a purchase and read whether an offer is realistic.
Starch and sugar feedstock
Mannitol starts from a starch-derived sugar syrup, so maize and wheat markets feed in alongside hydrogen and energy costs.
- Agricultural cycles drive the feedstock
- Hydrogen cost follows natural gas
- We flag feedstock-driven moves in the quote
Isomer separation yield
Hydrogenation gives mostly sorbitol; mannitol is the minor product, and that yield ratio is the main reason it costs more.
- Mannitol is the harder isomer to get
- Sorbitol demand affects mannitol supply
- Contracted call-off smooths the exposure
Grade tier
Food, tableting, direct-compression and parenteral grades carry very different processing and testing burdens.
- Parenteral grade is a separate product
- DC grades carry a spray-drying premium
- We will say when a lower tier will do
Freight and pack format
Denser than most excipients, so freight is less punishing — but clean packing for parenteral use adds cost.
- Compare on landed cost
- Clean packing costs more, correctly
- We quote FOB, CIF, CFR or DDP as you prefer
Source qualification lead time
Changing mannitol source on a lyophilised product means repeating cycle development — the real cost of a supply gap.
- We hold a second qualified source on this line
- Qualify the alternate before you need it
- Ask us about dual-source contracts
Confectionery & biologics demand
Sugar-free confectionery and freeze-dried biologics both draw on the same material and can tighten availability independently.
- Ask us what adjacent demand is doing
- Long-term contracts lock in supply
- We hold inventory on fast-moving grades
| If your application is… | Specify |
|---|---|
| Direct compression / ODT | Spray-dried DC grade |
| Chewable tablets | Granular or DC grade |
| Wet granulation | Fine powder grade |
| Freeze-dried product | Parenteral grade, low endotoxin |
| Injectable solution | Parenteral grade, particulate controlled |
| Sugar-free confectionery | Food grade E421 |
Not sure which row you are in? Describe your dosage form and your API and our technical desk will recommend the grade — including telling you when a cheaper grade would do the job just as well.
Support that goes beyond shipping the pallet
What our technical desk will do
- Establish the application before the grade. Parenteral, DC and standard powder are genuinely different products, and getting that wrong is expensive in a way a price difference is not.
- Confirm which pharmacopoeias you cite. Multi-compendial material costs more, and there is no point paying for tests your filing does not reference.
- Flag the compressibility point. If you are switching from lactose, the DC grade is not optional — crystalline mannitol will not give you the tablets you expect.
- Get you the statement pack early. Nickel, endotoxin, BSE/TSE and elemental impurity data arrive with the sample, not after the order.
Regulatory & compliance notes
- Excipient change control is yours to manage. Tell us which products this feeds and we will treat source changes as notifiable rather than routine.
- Parenteral use raises the documentation bar. Endotoxin, particulates and manufacturing-site information all become part of the specification.
- Compendial monographs differ in detail. USP-NF, Ph. Eur., JP and IP are close but not identical; we confirm coverage rather than assuming harmonisation.
- Laxative labelling applies at high intake. Relevant for confectionery and high-dose nutraceutical products rather than conventional tablets.
None of the above is legal advice — your own regulatory affairs team owns the final compliance position for your import and your filing. What we commit to is accurate product identity data, correctly matched grades and complete documentation to work from.
From enquiry to delivered pallet
Send the specification
Grade (powder, granular, DC or parenteral), the pharmacopoeias you cite, quantity, pack preference and destination port.
Receive a firm quote
Pricing, lead time, packing and Incoterm confirmed in writing within 24 hours — our sourcing desk is staffed around the clock.
Qualify and approve
Sample dispatched with the full statement pack for your compression or freeze-drying trials. Batch COA shared for approval before release.
Ship and track
Freight booked, export documents issued, and the consignment tracked through transit and clearance to your plant.
Others in the Chelora range
What buyers ask us about Mannitol
What is mannitol used for?
Why choose mannitol over lactose?
Why does mannitol taste cool in the mouth?
Which grade should I use for direct compression?
Why is nickel content on the specification?
Is it suitable for parenteral and freeze-dried products?
What is the minimum order quantity?
How should we store it?
Do you manufacture this yourself?
Request pricing on Mannitol
Send your grade, the pharmacopoeias you cite, quantity, pack format and destination port. Our sourcing desk is available 24 hours a day, 7 days a week, and comes back with pricing, lead time and packing options.