Lactose Monohydrate Food Grade – Versatile Filler and Sweetener for Food and Pharmaceuticals
Basic Information
CAS Number: 5989-81-1
Molecular Formula: C₁₂H₂₂O₁₁·H₂O
Molecular Weight: 360.31 g/mol
Appearance: White or almost white crystalline powder
Particle Size: 60–200 mesh (customizable)
Solubility: Freely but slowly soluble in water; practically insoluble in ethanol (96%)
Sweetness: Mild, pleasant, and non-aggressive
Packaging: Available in 25 kg bags, drums, or custom packaging
Storage: Store in a cool, dry place, away from moisture and direct sunlight
Overview
Lactose monohydrate is a naturally occurring disaccharide sugar derived from milk. It is one of the most widely used excipients in the pharmaceutical and food industries due to its excellent physical properties, low sweetness, and high stability. As a food-grade product, it serves as a sweetener, filler, bulking agent, and carrier for flavors and active ingredients. Its free-flowing nature and good compressibility make it particularly valuable in tablet manufacturing and dry powder formulations.
Applications
Food industry: Used as a sweetener, filler, and texture modifier in baked goods, confectionery, dairy products, infant formula, and dry mixes.
Pharmaceuticals: Widely used as an excipient in tablets, capsules, and dry powder inhalers; acts as a binder, diluent, and carrier for active pharmaceutical ingredients (APIs).
Nutraceuticals: Serves as a carrier and bulking agent in dietary supplements and vitamin formulations.
Other uses: Used in the production of fermented foods, as a standard in analytical chemistry, and in animal feed formulations.
Key Benefits
Excellent flowability and compressibility for tablet and capsule production.
Mild, pleasant sweetness that does not overpower other flavors.
Stable under normal storage conditions.
Good solubility in water, allowing easy incorporation into liquids and wet mixes.
Available in various particle sizes (60–200 mesh) for different processing needs.
Safe and recognized as food-grade and pharmaceutical-grade material.
Recommended Use
Typical usage levels: 5–50% by weight in tablets; 1–20% in food applications. Optimize based on desired sweetness, texture, and processing requirements.
Handling and Storage
Store in a cool, dry, well-ventilated area, away from moisture, heat, and direct sunlight.
Keep containers tightly sealed to prevent caking and contamination.
Use appropriate personal protective equipment (gloves, dust mask) when handling.
Quality Assurance
Each batch is tested for purity, moisture content, particle size distribution, and microbial contamination to ensure compliance with food and pharmaceutical quality standards.