HS 2940.00

Lactulose

Lactulose is a semisynthetic disaccharide of galactose and fructose linked β-1,4.

The CAS number is 4618-18-2 and the molecular formula is C₁₂H₂₂O₁₁. It does not occur in nature and is produced by alkaline isomerisation of the glucose moiety of lactose to fructose.

The molecule is non-digestible in the human small intestine because no enzyme cleaves the β-1,4 link between galactose and fructose. It reaches the colon intact and is fermented by gut bacteria, which makes it both a clinically established osmotic laxative and a prebiotic.

We source bulk Lactulose from top China manufacturers for our partners. The manufacturers are in Shandong. A smaller requirement can ship in a combined container with other ingredients.

Please send the grade you need, the volume and your destination port, and we will come back with a solution and a price.

or call +86-21-6858 0751

Packaging: 250 kg plastic drum or 1,000 kg IBC tote

ISO 9001
HACCP
Halal
Kosher

Specifications

Item	Specification
Appearance	Clear, colourless to pale yellow viscous syrup
Lactulose Content	≥ 66.0% w/w (67% nominal syrup grade)
Specific Rotation [α]D20	-45.5° to -52.0° (anhydrous basis)
Galactose	≤ 11.0% w/w
Lactose	≤ 6.0% w/w
Epilactose	≤ 4.0% w/w
Fructose	≤ 1.0% w/w
Total Solids	74.0-80.0%
pH	3.0-7.0
Sulphated Ash	≤ 0.1%
Heavy Metals (as Pb)	≤ 0.5 mg/kg
Arsenic	≤ 1 mg/kg
Total Plate Count	≤ 100 CFU/g
Yeast and Mould	≤ 50 CFU/g
Salmonella	Negative/25g

Common Markets Grades

Lactulose is produced mainly as a 65 to 70 percent aqueous syrup and as a crystalline powder.

Pharmaceutical syrup grade is the dominant commercial form, used in laxative and hepatic encephalopathy products.

Crystalline lactulose is produced for tablet and powder-sachet formulations and for use as a prebiotic functional food ingredient.

Both food and pharmaceutical grades comply with the relevant pharmacopoeial monographs for assay, colour, and impurity profile.

Applications

Osmotic laxative for chronic constipation in adults and children
Treatment of hepatic encephalopathy by reducing intestinal ammonia absorption
Prebiotic fibre in functional yogurts and dairy drinks
Bifidogenic ingredient in infant follow-on formulas
Carbohydrate marker in the lactulose-mannitol intestinal permeability test
Functional food ingredient in fibre-enriched cereals and bars
Carrier and gentle sweetener in pharmaceutical liquid formulations
Reference substrate in studies of colonic fermentation
Sugar reduction with prebiotic positioning in chocolate and confectionery
Adjunct in animal feed for piglet and calf gut-health support
Component of synbiotic combinations with probiotic strains

Brands Using Lactulose

Widely-distributed consumer products that list Lactulose on the ingredient label.

Brand names, product names and logos are the property of their owners. They appear here as published evidence that the ingredient is used, taken from the brand's own label or website. Their appearance is not an endorsement, and it does not mean the brand buys from us or from any manufacturer listed on this site.

China Manufacturers of Lactulose

Top Lactulose manufacturers in China.

Company names and logos are the property of the manufacturers themselves. They are listed here because our own directory records them as producing this ingredient. A listing is not an endorsement by them, and we do not represent them or speak on their behalf.

How We Help Source Lactulose

Direct Factory Sourcing
We run the whole process: selecting the manufacturer from the top Chinese food ingredient producers, negotiating the price, verifying quality, and coordinating the logistics. You deal with us instead of with several factories at once.
Original Packaging and Documents from the Manufacturer
The manufacturer sends your Lactulose out of its own factory in the original packing, through to your destination port. The COA, COO, MSDS, TDS and any certifications reach you from the manufacturer as well.
Free Samples and Lead Time
We send 100 to 500 g free for your own laboratory to test and you cover only the courier, usually within 2 to 3 working days. ETD is usually within 7 to 15 days once the order is confirmed, and we check that date against the factory's own manufacturing schedule before we give it to you.
Combined Shipment
We can load Lactulose together with other ingredients such as Fructooligosaccharides, Dextrose and Dextrose Monohydrate into one 20' FCL. If your quantity is small, we can also ship LCL.

Regulatory Status

Lactulose is registered as a pharmaceutical medicine in most major markets, with monographs in the USP-NF, European Pharmacopoeia, Japanese Pharmacopoeia, and Chinese Pharmacopoeia.

Food-use approval as a functional food ingredient exists in Japan, where lactulose carries Foods for Specified Health Use status, and in several European member states for infant nutrition.

The European Food Safety Authority has reviewed lactulose for use in infant nutrition.

The World Health Organisation lists lactulose on its Model List of Essential Medicines.

Manufacturing Process

Lactulose Manufacturing Process

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Lactulose is produced from lactose by alkaline isomerisation.

Lactose dissolved in water is treated with a base such as sodium hydroxide or calcium hydroxide, sometimes in the presence of borate as a complexing aid. The base catalyses the Lobry de Bruyn-Van Ekenstein rearrangement of the glucose moiety to fructose, leaving the galactose intact.

The crude reaction mass contains lactulose, unreacted lactose, galactose, and minor degradation products. Borate is removed by ion exchange.

The solution is decolorised with carbon, demineralized, and concentrated. For pharmaceutical syrup the concentrate is standardised to 65 to 70 percent solids. For crystalline product the syrup is crystallised under controlled conditions.