SoleChem

Lactose monohydrate

CAS
64044-51-5
EC
613-418-9
Mol. Weight
360.31 g/mol

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.

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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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