LACTOSE | CAS 63-42-3

Product Overview

Lactose (CAS: 63-42-3) is a naturally occurring disaccharide carbohydrate composed of two simple sugar molecules, glucose and galactose, joined together by a chemical bond. It is a white to off-white crystalline powder or solid with a mildly sweet taste, approximately 70% as sweet as sucrose. Lactose is the principal sugar found in mammalian milk and is commonly known as milk sugar.

Lactose is widely used across the pharmaceutical, food, and cosmetic industries due to its excellent solubility, stability, compatibility with active ingredients, and versatile functional properties.

Product Description

Lactose is a white crystalline powder or hard crystalline mass, odorless or with a slight characteristic odor. It is freely but slowly soluble in water (5-10 g/100 mL at 20°C) and practically insoluble in ethanol (96%). The compound exists in two isomeric forms: alpha-lactose and beta-lactose. Commercial lactose is typically the alpha-form.

Lactose is produced from whey (the liquid remaining after milk curdling), which contains approximately 5% lactose. The production process involves heating or treating with lime, removing proteins, concentrating, cooling, crystallizing, and drying. The product has a reducing property and is dextrorotatory (right-handed optical rotation).

Technical Specifications

Applications

Pharmaceutical Industry (Excipient)

Lactose is one of the most widely used pharmaceutical excipients in oral solid dosage forms. It acts as a:

• Filler / Diluent / Bulking Agent: Used in tablets and capsules to support fill weight, blend uniformity, and powder handling

• Binder: Contributes to compaction behavior and tablet integrity

• Flow Agent: Improves powder flow properties during manufacturing

• Disintegrant: Aids in tablet disintegration for drug release

Lactose is available in multiple pharmaceutical grades including anhydrous lactose, lactose monohydrate, spray-dried lactose, and inhalation-grade lactose. Anhydrous lactose is particularly valued for direct compression applications, enhancing tablet hardness, wear resistance, and dissolution performance. Spray-dried lactose grades (such as Fast Flo) are ideal for direct compression due to excellent flowability and compactability.

In capsule formulations, lactose serves as a diluent to support fill weight and blend uniformity. Pharmaceutical-grade lactose is manufactured under cGMP conditions and complies with international pharmacopoeia standards including USP, NF, Ph. Eur., and JP.

Food Industry

Lactose is widely used as a food additive and functional ingredient. Key applications include:

• Infant Formula: Essential carbohydrate source mimicking human milk composition

• Bakery Products: Helps preserve moistness and tenderness, maintains flavor quality, accentuates color development during baking, contributes to toasted flavors, and controls mold growth to extend shelf life

• Confectionery: Enhances texture and provides mild sweetness

• Powdered Mixes, Soups, Sauces, Seasonings: Functions as a carrier, bulking agent, and flavor enhancer

• Meat Products and Snacks: Improves texture and flavor

Lactose also serves as a dispersing agent for food colorants, reducing color concentration for easier use and minimizing discoloration during storage. Its low caramelization temperature (129.5°C) makes it suitable for baked goods requiring deep color development at lower baking temperatures.

Cosmetics & Personal Care

Lactose functions as a skin conditioning agent and humectant in cosmetic formulations. It is used in cleaning products, personal care items, and cosmetics.

Other Applications

• Lyophilization Aid: Used in freeze-dried pharmaceutical and food products

• Tonicity Agent: Adjusts osmotic pressure in formulations

• Pharmaceutical Fermentations: Serves as a carbon source in fermentation processes

• Veterinary and Homeopathic Products: Used as a carrier and diluent

Key Benefits

• Excellent solubility, stability, and compatibility with active pharmaceutical ingredients

• Versatile functionality as filler, binder, flow agent, and disintegrant

• Available in multiple grades: anhydrous, monohydrate, spray-dried, and inhalation grades

• Meets international pharmacopoeia standards (USP, NF, Ph. Eur., JP)

• Cost-effective and globally available excipient

• Free-flowing and non-hygroscopic, facilitating ease of manufacturing

• Enhances texture, shelf life, and flavor in food applications

• Mild sweetness (approximately 70% of sucrose)

• Naturally derived from milk, with a well-established safety profile

Packaging Options

Packaging Details:

• Standard packaging: Polyethylene-lined fiber drum with tamper-evident seals

• Inner liner: PE liner to protect from moisture

• Custom labeling and packaging specifications available upon request

Storage Recommendations:

• Store in a cool, dry, well-ventilated area

• Keep container tightly closed when not in use

• Protect from moisture, light, and strong oxidizing agents

• For long-term storage, store in a cool, dry place