Lactose monohydrate

Lactose monohydrate (CAS 64044-51-5) is a natural disaccharide sugar derived from whey, the liquid byproduct of cheese and dairy production. It is commercially available under trade names including Fast-Flo 316, Prismalac 40, Spherolac 100, and Spherolac 100, and carries no assigned E-number in the EU.

In pharmaceutical manufacturing, lactose monohydrate serves as a direct-compression excipient and filler-binder in tablet and capsule formulations, providing consistent flow and compressibility without interfering with active ingredients. In food production, it functions as a mild flavoring agent and carrier for spray-dried flavors and seasonings, where its low sweetness intensity and hygroscopic stability support controlled release and blending uniformity.

Lactose monohydrate is supplied in pharmaceutical-grade (Ph.Eur., USP/NF) and food-grade (FCC) specifications, with particle size variants including milled, sieved, and agglomerated forms to suit specific processing requirements. The substance is fully REACH-registered and available in multi-layer paper bags and bulk containers.