Lactose Monohydrate
The milk-sugar hydrate supplied by Chelora Chemicals — the most widely used diluent in tablet and capsule manufacture worldwide, valued for its consistent compressibility and compatibility — exported from Indonesia in bags with full batch documentation on every shipment.
What Lactose Monohydrate is, and why buyers source it
A working overview of the compound's chemistry, its role as the dominant tablet diluent worldwide, and the grades Chelora Chemicals keeps in regular supply.
Lactose Monohydrate is a disaccharide of galactose and glucose, crystallised with one molecule of water of hydration locked into its crystal lattice. That crystalline hydrate form is chemically stable, non-hygroscopic beyond its bound water, and reliably compressible, which together with its bland taste, low cost and well-characterised, highly consistent supply chain is why it has been the default tablet diluent for the pharmaceutical industry for decades.
It is a white to off-white, crystalline powder or granulated material, freely soluble in water and sparingly soluble in ethanol. It is chemically and physically stable under normal pharmaceutical storage conditions, though it is incompatible with primary amine-containing drugs (via the Maillard browning reaction) and this compatibility must be checked during formulation development.
Where it fits in the formulation chain
Lactose Monohydrate's primary use is as the diluent (bulking agent) in both direct-compression and wet-granulation tablet formulations and in hard-capsule filling, providing the bulk needed to make a low-dose active ingredient into a practically sized, manufacturable dosage unit. Different particle-size and granulation grades (fine milled grades for wet granulation, coarser spray-dried or agglomerated grades for direct compression) are selected to match the manufacturing process.
Grades we supply
Chelora Chemicals offers Lactose Monohydrate across standard milled and direct-compression (agglomerated/spray-dried) particle-size grades compliant with USP/EP/JP monographs, supplied with a batch-wise certificate of analysis.
How Lactose Monohydrate is made
An overview of the production route for orientation purposes. Our manufacturing partners' own process parameters and in-process controls are proprietary and are not disclosed beyond what is needed to interpret the certificate of analysis.
Lactose Monohydrate is manufactured by crystallising lactose, isolated and purified from whey (a by-product of cheese and casein manufacture), under controlled cooling conditions that favour formation of the alpha-lactose monohydrate crystal form. The crystallised material is then separated, washed, dried under conditions that preserve the bound crystal water, and milled or further processed (spray-dried, agglomerated) to the required particle-size grade.
Why crystallisation from whey is the standard process
Because lactose is already present in large quantities in whey, a by-product stream from an enormous existing dairy industry, controlled crystallisation is a straightforward, highly scalable and cost-effective way to isolate pharmaceutical-grade lactose, which is why it has been the standard production method since lactose was first adopted as a tableting excipient.
Industries and processes that use it
Lactose Monohydrate is consumed across the vast majority of solid oral dosage-form manufacture, where its reliable bulking and compression behaviour is the main draw. The fields below account for most of the demand we see through our export desk.
Direct-Compression Tableting
Agglomerated or spray-dried grades are used as the primary diluent in direct-compression tablet formulations, valued for good flow and compressibility.
Wet-Granulation Tableting
Fine milled grades are used as a diluent in wet-granulation formulations, where their consistent particle size supports uniform granule formation.
Hard-Capsule Filling
Used as a diluent in hard-capsule formulations to achieve the desired fill weight and flow characteristics for capsule-filling machinery.
Dry Powder Inhalers (DPI)
A specially sized, inhalation-grade lactose is used as a carrier particle in dry powder inhaler formulations to improve fine-particle drug dispersion and dosing uniformity.
How the molecule is typically carried forward
The crystalline hydrate structure governs almost all of this material's functional behaviour as a tablet diluent. The mechanisms below account for most of how Lactose Monohydrate performs its bulking and compression role.
Crystallisation (Upstream)
Lactose crystallises from purified whey solution under controlled cooling to form the alpha-lactose monohydrate crystal structure used as the pharmaceutical excipient.
Brittle Fracture Under Compression
Under compression force, lactose monohydrate crystals undergo brittle fracture, creating fresh particle surfaces that bond together, a key mechanism behind its compressibility.
Dissolution (Disintegration Aid)
Being freely water-soluble, lactose dissolves readily once the tablet disintegrates, aiding complete and rapid release of the active ingredient.
Maillard Reaction (Incompatibility Pathway)
The reducing-sugar character of lactose can react with primary amine-containing drugs via the Maillard reaction, causing browning and degradation — a key compatibility check in formulation development.
Lactose Monohydrate against other amines we supply
Buyers sourcing Lactose Monohydrate for tablet, capsule or inhalation-product manufacture often need a related tableting diluent. A quick reference to what else is on our regular supply list.
| Product | CAS Number | Category | Notes |
|---|---|---|---|
| Lactose Monohydrate | 64044-51-5 | Disaccharide hydrate diluent | The product on this page — the most widely used tablet diluent worldwide. |
| Mannitol | 69-65-8 | Sugar alcohol diluent | The lactose-free sugar-alcohol diluent commonly used as an alternative — see its product page. |
| Microcrystalline Cellulose | 9004-34-6 | Purified crystalline cellulose | Another standard diluent, often co-processed or blended with lactose — see its product page. |
| Magnesium Stearate | 557-04-0 | Fatty-acid magnesium salt lubricant | The standard lubricant used alongside lactose in most tablet formulations — see its product page. |
Exact physical constants and purity specifications are confirmed per batch on the certificate of analysis — treat the notes above as a sourcing guide, not a specification sheet, for products other than Lactose Monohydrate.
Safety classification at a glance
Based on GHS classification as commonly listed for this substance. This is a summary for orientation only — always work from the current safety data sheet supplied with your specific batch.
Not classified as hazardous under GHS; a long-established, widely used pharmaceutical excipient.
Fine powder may cause transient mechanical irritation to eyes or respiratory tract; handle with standard dust control.
No significant acute toxicity hazard under normal pharmaceutical handling.
Of dairy origin; relevant to lactose-intolerant patients and formulations claiming to be lactose-free.
Standard dust mask and gloves are sufficient for routine handling in a pharmaceutical manufacturing environment.
Keep dry and sealed to preserve crystal-water content and prevent microbial growth in humid conditions.
Follow standard pharmaceutical good manufacturing practice (GMP) for handling and cross-contamination control.
Not Classified — no GHS hazard pictogram applies to this excipient.
This material is not classified as hazardous under GHS and presents no significant acute toxicity hazard under normal pharmaceutical handling, though fine powder may cause transient mechanical irritation to eyes or the respiratory tract and should be handled with standard dust control. Being of dairy origin, it is relevant to lactose-intolerant patients and to formulations claiming to be lactose-free, a labelling and formulation consideration rather than a handling hazard. Full handling and storage guidance is in the MSDS issued with every shipment, and standard pharmaceutical GMP practice should be followed.
Keeping it on spec between delivery and use
General storage guidance for this grade. Site-specific storage rules, segregation requirements and re-test intervals should follow your own EHS procedures and the MSDS issued with your batch.
Store in a cool, dry area in tightly sealed original packaging, away from moisture and humid storage conditions, to preserve crystal-water content and prevent microbial growth. As a chemically stable, well-characterised crystalline material it is comparatively straightforward to store under standard pharmaceutical warehousing conditions. If a batch is held past its retest date, re-check moisture content and particle size before use.
How it ships from Indonesia
Standard packing and export terms for this product. Confirm exact figures against your order — they vary slightly by destination and quantity.
What travels with every batch
Specification is agreed before the purchase order, not discovered on arrival. Every shipment of Lactose Monohydrate leaves with a documented, checkable paper trail.
Certificate of Analysis
Batch-wise assay (by titration/GC), colour and relevant physical constants, issued against the agreed specification so your QC team can check it, not just file it.
Safety Data Sheet
GHS-format SDS in English covering hazard classification, handling, storage, first-aid and spill response for the exact grade of Lactose Monohydrate shipped.
Technical Data Sheet
Reference physical and chemical properties, recommended storage and typical applications, for internal circulation to your process or R&D teams.
Certificate of Origin
Confirms Indonesian origin for customs clearance and any preferential-duty claim at your destination port.
Dangerous Goods Declaration
UN packing group, classification and shipper's declaration prepared ahead of loading so documentation never holds up customs.
Third-Party Inspection
Independent pre-shipment inspection and re-sampling can be arranged on request, at your cost, for buyers who require it as a matter of policy.
Frequently asked questions
What buyers most often ask our sales desk about this grade.
01What is Lactose Monohydrate used for?+
02What is the CAS number of Lactose Monohydrate?+
03How is Lactose Monohydrate made?+
04What grades does Chelora Chemicals supply?+
05Why is Lactose Monohydrate not used with every drug?+
06Is Lactose Monohydrate hazardous?+
07What packing options are available?+
08How long does delivery take?+
09Can I get a sample before placing a bulk order?+
10Do you supply Mannitol and Magnesium Stearate as well?+
Need Lactose Monohydrate on spec, on time?
Send us your required purity, quantity, packing preference and destination port. Our desk quotes most enquiries within one working day.