Lactose monohydrate

CAS Number
64044-51-5
EC Number
613-418-9

What is Lactose monohydrate?

Lactose monohydrate (CAS 64044-51-5) is a natural milk-derived sugar; a crystalline powder used in food and pharmaceutical markets.

Where is Lactose monohydrate used?

  • Pharmaceutical tablets: filler and binder providing compressibility and flow for high-speed tableting
  • Dry powder inhalers: carrier particle delivering active pharmaceutical ingredients to the lungs
  • Food: mild sweetener and bulking agent in infant formula, confectionery coatings and dairy-based products
  • Nutraceutical and supplement capsules and sachets: diluent with a clean flavor profile
  • It serves primarily as a carrier, diluent and mild sweetener rather than a primary flavoring agent.

Good to know: Grades such as Pharmatose DCL 11 and Pharmatose 90M are recognized tablet-manufacturing specifications; Zeparox designates a specific milling grade for dry powder inhalation. Quality standards include Ph. Eur., USP/NF, BP and FCC.

Commercial specifications

  • Range of particle size distributions tailored to end-use requirements
  • Inhalation-specific and direct-compression grades available

Other Names (Synonyms)

Zeparox|Pharmatose DCL 11|Pharmatose 90M|Pharmatose 50M|Pharmatose 325|Pharmatose 150M|4-O-beta-D-Galactopyranosyl-alpha-D-glucopyranose monohydrate|alpha-Lactose monohydrate

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What are the physical properties of Lactose monohydrate?

Melting Point 217 °C
Density 1.31 g/cm³ (solid)
Appearance white or cream powder
Color White
Form Crystalline
Water Solubility Soluble in water (warm) (0.1 g/mL), and ethanol (very slightly soluble). Insoluble in chloroform, and ether.
pH 3.5-6.0 (25℃, 0.5M in H2O)
Log P -3.409 (est)

Which trade and regulatory codes apply to Lactose monohydrate?

HS Code 17021900
Storage Class 11 - Combustible Solids
WGK (Germany) 3
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