Lactose Monohydrate
Lactose is the most-used excipient in the world, and it earned that position on cost, flow and a hundred years of compendial history rather than on any clever property. The one thing it will not tolerate is a primary amine — and knowing that is most of what you need to know about specifying it.
Chelora Chemicals supplies lactose monohydrate to pharmaceutical, nutraceutical and food manufacturers worldwide, across milled, sieved and direct-compression grades, with a batch COA, GHS safety data sheet and the origin and allergen statements your QA file needs.
Product identity
- CAS Number
- 64044-51-5
- Compendial name
- Lactose Monohydrate
- Molecular formula
- C₁₂H₂₂O₁₁ · H₂O
- Molecular weight
- 360.31 g/mol
- EC / EINECS
- 200-559-2
- Common grades
- 200 mesh · 100 mesh · sieved · spray-dried
- Pharmacopoeias
- USP-NF · Ph. Eur. · JP · IP · BP
- HS Code
- 1702 19*
* Confirm the exact HS heading with your customs broker — lactose can attract dairy-sector tariff treatment in some destinations, and the pharmaceutical end use may change the classification.
What Lactose Monohydrate is used for
Lactose monohydrate is a white to off-white crystalline powder, the disaccharide of glucose and galactose crystallised with one molecule of water. It is obtained from whey, a by-product of cheese manufacture, and purified to pharmaceutical standard — which is why its price moves with the dairy market rather than with petrochemicals.
Its dominant use is as a filler and diluent in solid dosage forms: it makes up the bulk of a tablet or capsule when the active occupies only a small fraction. It is also the standard carrier in dry powder inhalers, where coarse lactose crystals carry micronised drug particles and release them on inhalation.
Where it sits among fillers
- Lactose monohydrate (this product) brittle fracture, excellent flow, lowest cost — the default where there is no amine in the formulation.
- Microcrystalline cellulose plastic deformation and much stronger compacts; usually blended with lactose rather than replacing it. See that page.
- Mannitol non-hygroscopic, non-reducing and pleasant tasting; the usual substitute where lactose is incompatible. See that page.
- Anhydrous lactose the same sugar without water of crystallisation, preferred for moisture-sensitive actives.
A lactose–MCC blend is the single most common filler system in tableting — see the full excipient range.
Appearance and handling character
The material is free-flowing, only mildly hygroscopic, and stable under normal conditions. It is not classified as a hazardous substance. The handling considerations that matter are its milk origin — which brings allergen and TSE documentation with it — and its chemistry as a reducing sugar, which rules it out alongside primary and secondary amines.
| Parameter | Typical value |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms |
| Water content (KF) | 4.5 – 5.5% |
| Specific rotation | +54.4° to +55.9° |
| pH (10% solution) | 4.0 – 6.5 |
| Residue on ignition | 0.1% max |
| Protein & light-absorbing impurities | Conforms |
| Microbial limits | TAMC ≤ 100 cfu/g · absence of E. coli & Salmonella |
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. Particle size distribution is the figure that most affects performance — tell us your grade and we will quote against it.
| Grade | Character / typical use |
|---|---|
| 200 mesh (milled) | Fine · wet granulation |
| 100 mesh (milled) | Medium · granulation & capsule fill |
| Sieved / crystalline | Coarse, free-flowing · capsule filling |
| Spray-dried | Amorphous content · direct compression |
| Agglomerated / granulated | Good flow and compressibility · direct compression |
| Inhalation grade | Controlled coarse fraction · DPI carrier |
Grade names and mesh conventions differ between producers. Send us the brand and grade you currently buy and we will cross-reference it rather than guessing from a mesh number.
Where our customers put this excipient to work
Mostly it is simply the bulk of the tablet — but the inhalation application is a genuinely demanding one.
Wet granulation filler
Milled 200 mesh lactose is the standard diluent in wet-granulated tablets, where the granule supplies flow and the lactose supplies bulk.
- 200 mesh is the usual grade
- Pairs with PVP K30 as binder
- Blend trials supported
Direct compression
Spray-dried and agglomerated grades carry enough amorphous content to compress properly, usually blended with MCC.
- Spray-dried or agglomerated grade
- Pairs with MCC PH-102
- Compressibility data available
Dry powder inhaler carrier
Coarse, tightly controlled lactose crystals carry micronised drug and release it under inhalation airflow — the most demanding lactose application there is.
- Inhalation-grade specification
- Fine-particle fraction critical
- Technical desk review of your route
Hard capsule filling
Sieved crystalline grades flow freely into dosators and give consistent fill weight without a heavy glidant load.
- Sieved or 100 mesh grades
- Pairs with magnesium stearate
- Bulk density reported per batch
Nutraceutical & food use
Used as a bulking agent in supplement tablets and powdered blends, and widely in infant and dairy formulations.
- Food-grade specification available
- Kosher and halal statements
- Allergen declaration supplied
Contract & scheduled supply
Lactose moves in large volumes and in a market tied to dairy cycles. We hold inventory and release it against your production calendar.
- Annual contracts with scheduled call-off
- Price held across the contract period
- Second source held in reserve
How we supply Lactose Monohydrate
Chelora Chemicals is a supplier and sourcing partner, not a manufacturer. On a dairy-derived excipient with real supply-chain documentation attached, owning no plant means we are never defending our own grade — we route your order to the producer whose particle size and documentation actually match your formulation.
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. Lactose availability follows the dairy market, which does not move in step with the chemical industry, so a qualified alternate is worth having.
- Grade cross-referenced before we quote. Mesh conventions differ between producers; send the brand you use and we will identify the true equivalent.
- We will raise the amine incompatibility before you order. If your active is a primary or secondary amine, we say so, even when it means recommending mannitol instead.
- Allergen and TSE statements as standard. Milk origin brings documentation obligations, and they arrive with the material rather than on request.
- Particle size distribution reported. On an inhalation grade the fine-particle fraction is the specification, and we treat it that way.
- Batch COA shared before dispatch. You approve the batch against your own spec while the material is still in our warehouse.
- 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
Lactose moves in volume, so pack format and container utilisation drive the landed cost. Tell us how it will be charged at your end and we will quote the format that suits your operation.
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 inhalation grades.
Jumbo bags (FIBC)
Lined, discharge-spout FIBCs for high-volume users with bulk-bag handling, cutting manual bag tipping out of the process.
Trial / sample quantities
Small packs dispatched so your formulation team can run compression or DPI trials before committing to a grade.
Incoterms to suit you
Quoted on the Incoterm your purchasing team works to, with export and dairy-origin documentation filed before the booking.
Campaign despatch
We hold contracted tonnage and release it against your production calendar instead of filling your warehouse at once.
A food ingredient, with real documentation attached
Lactose is not classified as hazardous — it is a food. What it brings instead is a documentation obligation: milk origin means allergen and TSE statements, and reducing-sugar chemistry means a stability question with amine actives. 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.MILKMilk-derived — allergen and intolerance considerations apply.ATEXCombustible organic dust — precautions apply in enclosed handling.
The milk-origin point is a labelling and patient-safety matter rather than an occupational one, but it belongs on your incoming specification and in your finished-product labelling assessment. Always read the SDS issued with your specific batch.
Practical handling notes
- Check for amines before you formulate. Browning on stability is the Maillard reaction and it cannot be formulated around — it means changing filler.
- Keep it away from strong odours. Lactose picks up volatile compounds readily and carries them into the dosage form.
- Watch for caking in humid stores. It is only mildly hygroscopic, but a humid warehouse will still cake an opened bag.
- Extract at tipping points. Nuisance dust at a bag tip is the commonest comfort complaint on this product.
- Clean up by vacuum. Sugar dust on a damp floor becomes sticky rather than slippery, but it is still best collected dry.
Storage
- Cool, dry, well-ventilated store. Ordinary warehouse conditions with humidity control; no temperature control is needed.
- Keep containers tightly closed. Caking in a part-used bag is the usual consequence of a torn or unsealed liner.
- Segregate from strongly scented materials. Adsorbed odour carries into the finished dosage form, and lactose is particularly prone to it.
- Keep off the floor and away from external walls. Standard GMP warehousing practice.
- Shelf life typically 36 months. In sealed original packing. Re-test against your specification after extended storage.
Handling & PPE
- Standard GMP powder handling. Local exhaust at tipping points, gloves, safety glasses and a dust mask where airborne powder is generated.
- Dedicated equipment for inhalation grades. Particle size integrity matters on a DPI carrier, and handling can generate fines that change the fine-particle fraction.
- Mind the allergen control plan. A milk-derived material in a shared facility belongs in your cross-contamination assessment.
- Static control on transfer. Earthed equipment where the material is conveyed pneumatically.
- Dispose of as ordinary non-hazardous waste. Subject to your local waste classification.
Transport
Lactose monohydrate is not a regulated dangerous good and ships as general cargo by road, sea and air. Some destinations apply dairy import controls and veterinary certification to lactose, so we confirm the position before booking — ask us for the full document pack when you plan the shipment.
What travels with every consignment
On a dairy-derived excipient the documentation reaches further than usual — origin, allergen and sometimes veterinary certification all travel with the pallet.
Certificate of Analysis
Batch-specific water content, specific rotation, pH, residue on ignition, particle size and microbial limits against the monographs you cite.
TSE & origin statement
Formal confirmation that the lactose derives from milk fit for human consumption, with the TSE risk position stated in writing.
Allergen & residual protein
Milk allergen declaration and residual protein data, which your labelling assessment will need in several markets.
Particle size distribution
Full PSD reported per batch, with fine-particle fraction data on inhalation grades where it is the governing specification.
Veterinary & dairy certification
Health certificates and dairy-origin documentation arranged where the destination applies veterinary import controls.
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 from whey, crystallised and milled
Everything that makes lactose useful — and the one thing that makes it a problem — follows from the fact that it is a reducing disaccharide crystallised from a dairy stream. The steps below are the general industrial pattern, not a process disclosure.
Concentrate the whey
Whey from cheese manufacture is clarified and concentrated until lactose approaches saturation.
Crystallise the alpha monohydrate
Controlled cooling crystallisation grows alpha-lactose monohydrate crystals, which are separated and washed.
Refine to pharmaceutical grade
Recrystallisation and purification bring protein, colour and microbial levels down to the compendial requirements.
Mill, sieve or spray-dry
The final processing step defines the grade — milling for granulation grades, spray drying for direct compression.
Why particle size and the amine question decide everything
Two bags can both meet the monograph exactly and still be entirely wrong for your formulation:
- Particle size is the grade. The compendial tests barely distinguish 200 mesh from spray-dried; the PSD and the amorphous content do, and those are what you are actually buying.
- Amorphous content drives compressibility. Spray-dried lactose compresses because it is partly amorphous — and that same amorphous fraction is less stable to moisture.
- Maillard browning is not reversible. With a primary or secondary amine active you will see discolouration on stability, and no change of grade will fix it.
- On a DPI carrier, the fines fraction is the product. The coarse crystals are just the carrier; the fine-particle fraction governs how much drug actually detaches on inhalation.
That is why we cross-reference the exact grade you use and ask about your active before quoting, and why the batch COA is shared for approval before dispatch rather than sent with the invoice.
| Material | Character / use |
|---|---|
| Lactose monohydrate CAS 64044-51-5 — this product | Standard filler · reducing sugar |
| Anhydrous lactose CAS 63-42-3 | Moisture-sensitive actives |
| Mannitol CAS 69-65-8 | Non-reducing · amine compatible |
| Microcrystalline cellulose CAS 9004-34-6 | Plastic deformation · usual blend partner |
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.
The dairy cycle
Lactose comes from whey, so cheese production volumes and dairy commodity prices drive availability in a way no chemical input does.
- Supply follows cheese output, not demand
- Seasonal milk cycles are visible in price
- We flag dairy-driven moves in the quote
Grade processing cost
Milled lactose is the cheapest grade; spray-dried and inhalation grades carry substantial additional processing.
- Inhalation grade is a different product
- Specify the grade you actually need
- Over-specification is the commonest cost leak
Freight and dairy import duty
Some destinations apply dairy-sector tariffs and veterinary controls to lactose, which can matter more than the freight itself.
- Check the tariff position before ordering
- We confirm destination rules before quoting
- We quote FOB, CIF, CFR or DDP as you prefer
Compendial coverage
Food-grade and pharmaceutical lactose come off related plants at different prices and documentation levels.
- Never cross-shop grades on price alone
- Pharma grade carries the statement pack
- We will say when food grade will do
Source qualification lead time
Changing lactose source changes your PSD and your compression behaviour, so requalification is 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
Infant nutrition demand
Infant formula consumes very large volumes of refined lactose and competes directly with pharmaceutical grades.
- Ask us what adjacent demand is doing
- Long-term contracts lock in supply
- We hold inventory on fast-moving grades
| If your process is… | Specify |
|---|---|
| Wet granulation | 200 mesh milled |
| Direct compression | Spray-dried or agglomerated grade |
| Capsule filling | Sieved crystalline or 100 mesh |
| Dry powder inhaler | Inhalation grade, PSD-controlled |
| Moisture-sensitive API | Anhydrous lactose |
| Primary or secondary amine API | Mannitol instead — not lactose |
Not sure which row you are in? Describe your API, your process and the grade you currently use and our technical desk will recommend the equivalent — or tell you when lactose is the wrong filler entirely.
Support that goes beyond shipping the pallet
What our technical desk will do
- Ask what your active is first. If there is a primary or secondary amine in the molecule, lactose is the wrong filler and we would rather say so than take the order.
- Cross-reference your current grade. Mesh conventions and brand names differ, and a wrong equivalence changes your compression profile.
- Get you the origin documentation early. Allergen, TSE and veterinary certification requirements vary by destination and are worth settling before the PO.
- Treat inhalation grades differently. On a DPI carrier the PSD specification is the product, and it needs handling as such from the first enquiry.
Regulatory & compliance notes
- Milk origin brings labelling obligations. Several markets require declaration of milk-derived excipients; confirm your position before you commit.
- Dairy import controls may apply. Veterinary certification is required at some destinations — we check before quoting, not after you have raised the PO.
- Compendial monographs differ in detail. USP-NF, Ph. Eur., JP and IP are close but not identical; we confirm coverage rather than assuming harmonisation.
- Lactose intolerance is a patient-facing issue. It belongs in your product information even though it is not a safety classification.
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 (200 mesh, sieved, spray-dried or inhalation), 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 origin, allergen and TSE statements for your formulation trials. Batch COA shared for approval before release.
Ship and track
Freight booked, dairy and export documents issued, and the consignment tracked through transit and clearance to your plant.
What buyers ask us about Lactose Monohydrate
What is lactose monohydrate used for?
What is the difference between 200 mesh and spray-dried grades?
What is it incompatible with?
Does it need an allergen declaration?
What about BSE/TSE status?
Which grade should I use for direct compression?
What is the minimum order quantity?
How should we store it?
Do you manufacture this yourself?
Request pricing on Lactose Monohydrate
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.