Lactose, Monohydrate, Spray-Dried Powder, NF
Elevate your pharmaceutical formulations with our Lactose, Monohydrate, Spray-Dried Powder, NF. This high-purity excipient is specifically designed to enhance tablet formulation, boasting excellent compressibility properties that ensure consistent performance in various applications.
Key Features:
- Chemical Formula: C12H22O11·H2O
- Formula Weight: 360.31 g/mol
- Function: Acts as a diluent for tablets and capsules, and is suitable for dry-powder inhalations.
Chemical Characteristics:
| Chemical Specs |
Clarity and Color of Solution: To pass test
Specific Rotation, [?]D20: +54.4° to +55.9°
Acidity or Alkalinity: To pass test
Water: 4.5% - 5.5% |
| Microbial Limits |
Total Aerobic Microbial Count: 100/g
Total Molds and Yeasts: 50/g
Test for Escherichia coli: Negative |
| Other Specifications |
Loss on Drying: 1.0%
Residue on Ignition: 0.1%
Heavy Metals: ≤ 5 ppm
Protein and Light-Absorbing Impurities: To pass test
Residual Solvents: To pass test |
Safety Information:
| Ratings |
| Health: 1 |
| Flammability: 1 |
Regulatory Compliance:
All Lactose, Monohydrate, Spray-Dried Powder, NF products are manufactured, packaged, and stored under current Good Manufacturing Practices (cGMP), adhering to the highest standards of safety and quality. This product falls under the category of Sugars and is regulated by the FDA.
Physical Characteristics:
This spray-dried lactose powder ensures optimal functionality in pharmaceutical applications, providing reliable performance as a tablet/capsule diluent and aiding in the development of high-quality inhalation products.
