Pharma Excipient · Tablet Diluent · DPI Carrier
Lactose monohydrate (milk sugar), one of the most used fillers in tablets and capsules and the classic carrier in dry powder inhalers. Supplied in IP, BP, USP-NF and EP grades by Chelora Pharmachem, Mumbai, and delivered across India with a batch COA and SDS.
How Buying Works
Send the quantity, grade (IP, BP, USP-NF or EP), type (milled, sieved or spray-dried) or mesh size, city and date. Quote CAS 64044-51-5 so there is no confusion.
Price, lead time and packing in one reply, with the specification, COA and SDS/MSDS for your QA team to review.
Samples can be arranged for QC testing, granulation, compression or capsule-filling trials and vendor qualification before your order.
Packed, labelled and sent with invoice, batch COA and transport documents. Repeat orders are planned with you.
Product Overview
Lactose monohydrate (α-lactose monohydrate, milk sugar, lactosum monohydricum; CAS 64044-51-5) is the crystalline monohydrate of lactose, the natural sugar of milk, built from one galactose and one glucose unit. It is a white or almost white crystalline powder that is freely but slowly soluble in water and practically insoluble in ethanol. Each molecule holds one molecule of water of crystallisation, about 5% by weight, which is why pharmacopoeias set a water limit of 4.5–5.5%. Anhydrous lactose is a different material with its own CAS number, 63-42-3.
Lactose monohydrate is one of the most widely used diluents (fillers) in tablets and capsules. It is stable with most actives, tastes only mildly sweet, dissolves readily and is made in many particle sizes. Milled grades suit wet granulation, sieved grades flow well for capsule and sachet filling, and spray-dried grades compress directly. Coarser inhalation grades act as the carrier in dry powder inhalers. It is also used in nutraceutical tablets, infant nutrition and food, and in microbiological culture media.
As a chemical supplier in Mumbai, Chelora Pharmachem supplies pharmacopoeia-grade lactose monohydrate to tablet, capsule, nutraceutical and inhalation manufacturers across India, with a batch-wise COA, SDS/MSDS and specification. Tell us the grade and particle size, such as 200 mesh milled, sieved or spray-dried, and we quote against your specification. We also supply Microcrystalline Cellulose (MCC), the filler-binder often blended with lactose in direct-compression tablets, and Magnesium Stearate, the usual lubricant for both.
In Depth
Lactose is a disaccharide: β-D-galactose joined through a 1→4 glycosidic bond to D-glucose. The glucose end can exist as an α or β anomer, and in solution the two interconvert (mutarotation) to roughly 40% α and 60% β at room temperature. α-Lactose crystallises from water as the monohydrate, holding one water molecule per sugar molecule, about 5% of its weight.
The free anomeric carbon on the glucose unit makes lactose a reducing sugar. With primary and secondary amine drugs it can undergo the Maillard reaction, which causes browning and, earlier on, loss of potency; amphetamine and fluoxetine are documented cases. Formulators check compatibility, or choose another filler such as MCC or mannitol, when the active carries a free amine.
Lactose is recovered from whey, the by-product of cheese and casein making. Proteins are filtered out, the lactose-rich permeate is concentrated and cooled so α-lactose monohydrate crystallises, and the crystals are separated, refined and dried. The dry crystals are then milled, sieved, agglomerated or spray-dried to make grades with different particle sizes and flow behaviour.
As a diluent, lactose brings small doses of active up to a weight that can be compressed or filled accurately. Fine milled grades bind well in wet granulation, free-flowing sieved grades fill capsules and sachets evenly, and spray-dried grades, which contain some amorphous lactose, compress directly with little or no granulation. It is water-soluble, so it does not slow tablet disintegration.
Confirm the pharmacopoeia (IP, BP, USP-NF or EP) and the grade type first: milled, sieved, spray-dried or inhalation. Then compare particle size distribution or mesh, bulk and tapped density, water content, specific optical rotation, microbial limits and elemental impurities. For DPI or low-dose products, ask for the full particle-size data and the batch COA and SDS.
Chelora Pharmachem supplies lactose monohydrate (CAS 64044-51-5) from its centralized sales office in Mumbai to formulation, nutraceutical, inhalation and food manufacturers across India. Share the grade, particle size or mesh, quantity, packing and delivery location, and our team replies with price, lead time and documents, from trial lots to regular bulk supply, with the same grade and particle size kept for repeat orders.
Global Sourcing
Our focus is the Indian market. When local supply is short, or you need a specific origin, particle-size grade or pharmacopoeia, our international sourcing desk brings lactose monohydrate in from trusted producers abroad, and our Mumbai team handles import, documents and delivery to your plant.
Product Profile
The identifiers and properties purchase and QA teams ask for first. Batch values are always confirmed on the COA.
Identity
EC 200-559-2. Anhydrous lactose is 63-42-3. Also sold as α-lactose monohydrate or milk sugar.
A galactose ring linked β(1→4) to a glucose ring, plus one water molecule.
Appearance
White or almost white crystalline powder, odourless, with a mildly sweet taste.
Solubility
Dissolves freely but slowly in water, faster when warm. Practically insoluble in ethanol.
Technical Data
Reference data for Lactose monohydrate, useful when writing a specification, checking an SDS or planning storage and transport.
| Property | Value |
|---|---|
| IUPAC name | 4-O-β-D-Galactopyranosyl-α-D-glucopyranose monohydrate |
| Synonyms | α-Lactose monohydrate, milk sugar, lactosum monohydricum, D-(+)-lactose monohydrate |
| CAS number | 64044-51-5 (monohydrate); 63-42-3 is anhydrous lactose; 5989-81-1 and 10039-26-6 are also used for α-lactose monohydrate |
| EC number | 200-559-2 (lactose) |
| PubChem CID | 104938 (α-lactose monohydrate) |
| Molecular formula | C12H22O11·H2O |
| Molar mass | 360.31 g/mol (342.30 g/mol anhydrous) |
| Appearance | White or almost white crystalline powder; odourless, mildly sweet |
| Water content | 4.5–5.5% (one molecule of water of crystallisation, about 5.0% in theory) |
| Melting point | Decomposes at about 200–220 °C, depending on heating rate; loses its water of crystallisation on heating |
| Specific optical rotation | +54.4° to +55.9° (anhydrous basis, Ph. Eur.) |
| Density | About 1.53 g/cm³ |
| Solubility in water | Freely but slowly soluble; about 19 g per 100 g of solution at 25 °C, about 37 g at 60 °C |
| Other solvents | Practically insoluble in ethanol (96%); insoluble in chloroform and ether |
| Sweetness | About 0.2–0.4 times that of sucrose |
| HS code | 1702.11 |
| Transport | Not regulated as a dangerous good for road, sea or air; confirm with the batch SDS |
Literature values for reference. Supplied material is tested batch-wise and reported on the COA.
Applications
Its main job is filling tablets and capsules. The same sugar, in coarser or finer grades, carries the drug in dry powder inhalers and turns up in nutrition products and lab media.
The most familiar use: lactose bulks up low-dose actives so tablets can be compressed to a practical size. Milled grades such as 200 mesh suit wet and dry granulation, while spray-dried and agglomerated grades are made for direct compression.
Oral solid dosage
Sieved, coarser grades flow freely and pack evenly, so capsule and sachet fill weights stay consistent from one dose to the next. Lactose is also used to dilute potent actives in powder triturates and pre-mixes before filling.
Hard-gelatin & HPMC capsules
In dry powder inhalers, a micronised drug only a few micrometres across is blended with coarser α-lactose monohydrate. The carrier helps the tiny drug particles flow and dose accurately, then releases them when the patient inhales. Inhalation grades have tightly controlled particle size.
Inhalation grade
Lactose is used as a carrier and filler in vitamin and supplement tablets, and as an ingredient in infant formula, confectionery, bakery and dairy products, where its mild sweetness and browning behaviour are useful. Food and pharma grades are specified separately.
Food & supplement grade
Lactose is a standard carbohydrate in culture media. Whether bacteria ferment it is a classic test for telling apart groups such as coliforms, and it is also used as a reagent and reference material in QC laboratories.
Culture media
Quality & Compliance
Every supply is backed by the documents your QA, regulatory and stores teams expect.
COA, batch-wise
Tests, limits and results for the exact batch you receive, shared before dispatch.
SDS / MSDS
Hazards, safe handling, storage, transport and first-aid measures for Lactose monohydrate.
Technical data
Typical properties and the specification we supply against, to match with your in-house spec.
On request
Additional documents for vendor approval and audits can be arranged on request.
Safety & Handling
A short summary for stores, production and EHS teams. It does not replace the Safety Data Sheet supplied with every batch.
Lactose monohydrate is generally not classified as hazardous under GHS, and major supplier SDSs require no hazard label. A few databases list mild irritation statements, so check the SDS of the batch for the classification that applies.
Wear safety glasses and gloves, and a dust mask where fine powder is handled in quantity. Use local exhaust ventilation at sieving, milling and charging points, and follow good hygiene practice.
Keep bags tightly closed in a cool, dry, well-ventilated store, away from moisture, strong odours and strong oxidising agents. Protect from heat; on burning it gives carbon monoxide and carbon dioxide.
Like other fine organic powders, its dust can form combustible clouds in air, so avoid dust build-up and ignition sources. It is not regulated as a dangerous good for road, sea or air transport.
Sweep up or vacuum spills without raising dust and collect them in closed containers for disposal. Lactose is readily biodegradable, but large quantities should still be kept out of drains and water courses.
PAN India Delivery
From our centralized sales office in Mumbai, we supply Lactose monohydrate to buyers in every major manufacturing cluster.
MumbaiMumbai, Thane, Navi Mumbai, Tarapur, Boisar, Pune and Aurangabad.
AhmedabadAhmedabad, Vadodara, Ankleshwar and Vapi.
HyderabadHyderabad and Visakhapatnam.
BaddiBaddi and Haridwar.
GoaPharma and chemical units across Goa.
BengaluruBengaluru and Chennai.
IndoreIndore, Pithampur and Sikkim.
Specification
A typical specification for pharmacopoeia-grade lactose monohydrate (IP / BP / USP-NF / EP). Share your in-house or pharmacopoeia specification and particle-size requirement, and we quote against it.
The Chemistry
Made
Whey from cheese making is filtered to remove protein, and the lactose-rich permeate is concentrated and cooled. Below about 93.5 °C lactose crystallises as α-lactose monohydrate, which is separated, refined, dried and then milled, sieved or spray-dried to grade.
Used
It is mixed with the active and other excipients, then granulated, compressed directly or filled into capsules. In DPIs it carries a micronised drug. Because it is a reducing sugar, check compatibility with actives that carry primary or secondary amines.
Tested
Each batch is reported on a COA covering appearance, identification, acidity or alkalinity, specific optical rotation, water, sulphated ash, absorbance and microbial limits, plus particle size for the grade, so your QC team can release it quickly.
Stored
Lactose monohydrate is stable but can pick up odours and, if damp, cake or support microbial growth. Keep bags closed in a cool, dry store away from strong oxidising agents, and follow the SDS for handling and dust control.
Glossary
Terms you will meet on quotations, specifications and documents for Lactose monohydrate.
FAQ
Anything else, call +91 98191 11179 or write to source@chelorapharmachem.com.
Request a QuoteLactose monohydrate (CAS 64044-51-5) is mainly used as a diluent or filler-binder in tablets and capsules, and as the carrier in dry powder inhalers. It is also used in nutraceutical tablets, infant formula and food products, and in microbiological culture media.
The CAS number is 64044-51-5. Its formula is C12H22O11·H2O and its molar mass is 360.31 g/mol. Some suppliers also use 5989-81-1 or 10039-26-6 for α-lactose monohydrate. Anhydrous lactose is 63-42-3, so quote the CAS number to avoid confusion.
Yes. Lactose is the sugar found in milk, and pharmaceutical lactose monohydrate is the purified crystalline α-lactose monohydrate form of it, also sold as milk sugar, α-lactose monohydrate or lactosum monohydricum.
Lactose monohydrate (CAS 64044-51-5) is α-lactose with one molecule of bound water, about 5% water. Anhydrous lactose (CAS 63-42-3) has almost no water and is mostly β-lactose. Anhydrous grades suit direct compression and moisture-sensitive actives; the monohydrate is the general-purpose filler.
Milled grades, such as 200 mesh, are fine and cohesive and suit wet granulation. Sieved grades are coarser and flow freely for capsule and sachet filling. Spray-dried grades have rounded particles with some amorphous lactose, so they flow and compress well for direct compression.
We supply pharmacopoeia grades to IP, BP, USP-NF and EP, in milled, sieved and spray-dried types, with inhalation and other special grades sourced on request, subject to availability. Tell us the mesh or particle-size requirement when you enquire.
Keep it in tightly closed bags in a cool, dry and well-ventilated store, away from moisture, strong odours and strong oxidising agents. Follow the storage section of the SDS supplied with the batch.
Pharmaceutical lactose is generally classified under HS subheading 1702.11, which covers lactose containing 99% or more lactose, expressed as anhydrous lactose on the dry matter. Confirm the full national tariff code with your customs broker before import or export.
It is generally not classified as hazardous, but fine dust can irritate the eyes and airways and can form combustible clouds. Products containing it may need lactose labelling for patients with lactose intolerance or galactosaemia. Read the batch SDS before handling.
No. Lactose monohydrate is not regulated as a dangerous good for road, sea or air transport. Always check the transport section of the SDS supplied with the batch.
We provide a batch-wise Certificate of Analysis (COA), SDS/MSDS and specifications. Additional documents for vendor qualification can be arranged on request.
Yes. We handle requirements from samples and trial lots for R&D, formulation and vendor approval up to regular bulk supply for commercial production, subject to product availability.
We supply buyers across India, including Maharashtra, Gujarat, Telangana, Andhra Pradesh, Himachal Pradesh, Goa, Karnataka, Tamil Nadu, Madhya Pradesh, Uttarakhand and Sikkim, from our centralized sales office in Mumbai.
Email source@chelorapharmachem.com or source@cheloragroup.com, call +91 98191 11179, or use the enquiry form on this page. Include the quantity, grade, delivery location and target date.
Request a Quote
Tell us the quantity, grade and delivery location. Our centralized sales team replies with competitive pricing, lead time and documentation.
