Anhydrous Lactose, NF – Premium Tablet Diluent for Pharmaceutical Applications
Discover the high-quality Anhydrous Lactose, NF, an essential ingredient widely utilized as a tablet diluent in the pharmaceutical industry. Known for its purity and effectiveness, Anhydrous Lactose facilitates the formulation of various solid dosage forms, ensuring optimal performance in tablet manufacturing.
Key Features:
- Chemical CAS Number: 63-42-3
- Chemical Formula: C12H22O11
- Chemical Formula Weight: F.W. 342.30
Chemical Specifications:
| Clarity and Color of Solution |
To pass test |
| Specific Rotation, [a]D20 |
+54.4° to +55.9° |
| Acidity or Alkalinity |
To pass test |
| Microbial Limits |
To pass test |
| Residue on Ignition |
0.1% |
| Heavy Metals |
5 µg/g |
| Protein and Light-Absorbing Impurities |
To pass test |
| Loss on Drying |
0.5% |
| Water Content |
1.0% |
| Residual Solvents |
To pass test |
Chemical Functionality:
The primary function of Anhydrous Lactose, NF is as a tablet and capsule diluent, making it indispensable in the pharmaceutical manufacturing process. Its unique properties help enhance the stability and bioavailability of active pharmaceutical ingredients.
Regulatory Compliance:
This product adheres to stringent quality standards and is manufactured, packaged, and stored under current Good Manufacturing Practices (cGMP). Additionally, it falls under the category of Sugars | FDA Regulated Items, ensuring that it meets the necessary safety and quality requirements for pharmaceuticals.
UPS Limit:
150 lb
