Lactose monohydrate
Description
Lactose monohydrate (CAS 64044-51-5) is a natural milk-derived sugar supplied as a crystalline powder across food and pharmaceutical markets. Grades such as Pharmatose DCL 11 and Pharmatose 90M are recognized specifications in tablet manufacturing.
Zeparox designates a specific milling grade for dry powder inhalation. Its primary industrial role is as a carrier, diluent, and mild sweetener rather than a primary flavoring agent in most commercial applications.
In solid dose pharmaceutical manufacturing, it functions as a tablet filler and binder, providing compressibility and flow properties that support high-speed tableting lines. These features are essential for modern production.
Inhalation-grade variants are used in dry powder inhalers as a carrier particle to deliver active pharmaceutical ingredients to the lungs. In food production, it acts as a mild sweetener and bulking agent.
Common food uses include infant formula, confectionery coatings, and dairy-based products. Nutraceutical and supplement manufacturers use it as a diluent in capsule and sachet formulations where a clean flavor profile is required.
The material is supplied as a white crystalline powder in a range of particle size distributions tailored to end-use requirements. Established quality standards include Ph. Eur., USP/NF, BP, and FCC.
These certifications cover both pharmaceutical and food applications globally. Inhalation-specific and direct-compression grades are available for specialized manufacturing processes to ensure consistent performance and safety.
Physical Properties
| 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) |
Trade & Regulatory
| HS Code | 17021900 |
| Storage Class | 11 - Combustible Solids |
| WGK (Germany) | 3 |
Documentation
Other Names
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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