Lactose

Lactose (CAS 63-42-3), commonly known as milk sugar, is a disaccharide derived from dairy whey and casein manufacturing streams.

Where is Lactose used?

• Pharmaceutical solid-dose manufacturing: most established excipient for tablet and capsule formulations
• Direct compression and wet granulation: bulk and consistent flow properties
• Dry powder inhalers: carrier particle for precise API doses to the respiratory tract
• Food production: infant formula, bakery mixes and confectionery for mild sweetness
• Baking: supports browning reactions
• Flavour encapsulation: spray-dry carrier
• The dairy and flavouring industries utilise it for colours and functional ingredients.
• Finer milled grades serve as fillers in tablet production by wet granulation or in applications requiring a small particle size.
• In dairy products, it delays moisture loss and minimizes syneresis.
• Bulk material is used as fermentation substrate for cultured dairy products and food biotechnology.
• Technical material is used in the manufacture of lactulose and special carbohydrate derivatives.

Good to know: Pharmaceutical grades include Ph. Eur., USP and BP, with sub-grades such as lactose monohydrate and anhydrous lactose. Food-grade material meets FCC specification.

Formulation notes

• Has a lower glycemic index (46) than sucrose (65) or glucose (103).
• At 16-40% sweetness, it is less sweet than sucrose (100%), fructose (110-120%) and glucose (70-80%).

Typical specification

• Spray dried lactose and anhydrous lactose are the two most important modified forms for use as a filler-binder in direct compression tablets.
• Each grade is produced with controlled sieve fraction (mesh), bulk density, flowability, solubility profile and moisture stability.
• Can be compressed into tablet form for confectionery applications.

Regulatory status

• Products carrying the "lactose-free" claim must state the specific residual lactose threshold on the label, e.g. "less than...", and the stated threshold must remain below 0.1 g per 100 g or 100 ml.
• For lactose-free infant formula the legal limit is 2.5 milligrams per 100 kilojoules (10 milligrams per 100 kilocalories).
• Only for milk and fermented milks may the claim "reduced lactose content" be used if the residual lactose is below 0.5 g per 100 g or 100 ml.
• Milk, milk products and lactose are among the 14 foods that most frequently trigger intolerances and must always be declared in the ingredient list of packaged goods, including in compound ingredients and in milk- or lactose-containing additives and flavours.

Frequently asked questions about Lactose

What additional labelling applies to delactosed products?

Delactosed products labelled "lactose-free" or "reduced lactose" must also carry a statement such as "The product contains glucose and galactose as a result of lactose splitting".

What status can pharmaceutical lactose offer?

Pharmaceutical lactose can offer BSE-free status and be Calf Rennet Free.

Technical content is compiled and updated by the SoleChem product team from public technical sources; the certificate of analysis (COA) governs product-specific specifications.