Lactose Monohydrate

ALTERNATIVE NAMES
Alpha-Lactose Monohydrate, Lactose 1H2O.

TECHNICAL SPECIFICATIONS

CAS
10039-26-6
EC
200-559-2
Food Code
-

Lactose Monohydrate is a crystalline Pharma Grade excipient containing one molecule of water. It is known for its superior flowability and is the industry standard for direct compression tableting.

This high-purity sugar is characterized by its high chemical stability and compatibility with diverse active ingredients. It serves as a reliable diluent that ensures weight consistency and tablet hardness in manufacturing.

In the food industry, it is used as a non-hygroscopic filler and browning agent. It provides bulk and texture to confectionery products while maintaining a low-intensity sweetness profile.

Lactose Monohydrate

  • Direct Compression: The preferred excipient for oral solid dosage forms due to its excellent binding and flow characteristics.
  • Dry Powder Inhalers (DPI): Utilized as a specialized carrier for inhaled drugs, where precise particle size is critical for delivery.
  • Bakery & Confectionery: Acts as a texture modifier and color enhancer through the Maillard reaction in premium baked goods.

Recognized as Generally Recognized as Safe (GRAS). No hazardous classification; however, standard PPE including safety glasses and gloves is recommended.

Supplied in 25 kg PE-lined Paper Bags or Fiber Drums to ensure moisture protection and pharmaceutical quality.

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