Lactose Monohydrate
Alpha-Lactose Monohydrate, Lactose 1H2O.
- CAS
- 10039-26-6
- EC
- 200-559-2
- Sectors
- Pharma & Healthcare, Food & Nutrition
Lactose Monohydrate (CAS 10039-26-6) is a crystalline Pharma Grade sugar excipient that contains one molecule of water, appears as a white or almost white crystalline powder, and is used as a diluent for direct compression tableting, a carrier in dry powder inhalers, and a filler in food. 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.
Typical Properties
| Molecular formula | C12H24O12 |
|---|---|
| Molecular weight | 360.31 g/mol |
| Appearance | White or almost white, crystalline powder. |
| Form | Solid |
| Color | white |
| Melting point | ~215 °C (dec.) |
| Density | 500kg/m3 |
| Water solubility | 161g/L |
| pH | 4.0-6.5 (20°C, 100g/L in water) |
| Grades available | Pharma Grade |
Typical literature values for identification; lot-specific results are stated on the certificate of analysis (COA) and the safety data sheet (SDS) that accompany every delivery.
Lactose Monohydrate
Applications
- 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.
Safety & Risks
Recognized as Generally Recognized as Safe (GRAS). No hazardous classification; however, standard PPE including safety glasses and gloves is recommended.
Packaging
Supplied in 25 kg PE-lined Paper Bags or Fiber Drums to ensure moisture protection and pharmaceutical quality.