TDS Lactose.pdf
Product Information
Common Name: Anhydrous LactoseCAS No.: 63-42-3
Molecular Formula: C₁₂H₂₂O₁₁
Molecular Weight: 342.30
Synonyms: β-Lactose, Milk sugar anhydrous
Chemphysical Properties
Appearance White crystalline powder
Specific Rotation [α]D²⁰ +54.4° ~ +55.9°
Melting point 214℃ (decomposition)
Solubility Soluble in water; slightly soluble in ethanol; insoluble in ether
Bulk density 0.60 ~ 0.80 g/ml
Hygroscopicity Low hygroscopicity at ambient temperature
Quality Specification
| Item | USP Grade | Food Grade |
|---|---|---|
| Assay (anhydrous basis), % | 98.5 ~ 101.5 | ≥99.0 |
| Water content, % | ≤0.5 | ≤1.0 |
| Heavy metals (Pb), ppm | ≤10 | ≤10 |
| Residue on ignition, % | ≤0.1 | ≤0.1 |
| Particle size | Custom mesh available | Custom mesh available |
Use & Application
USP grade anhydrous lactose is a premium excipient for pharmaceutical tablets and capsules. It acts as diluent, filler and binder, especially suitable for moisture-sensitive active pharmaceutical ingredients. It improves powder flow and tablet hardness, commonly applied in direct compression formulations.
Food grade anhydrous lactose functions as mild sweetener, carrier for food flavors and anti-caking agent. It is used in confectionery, bakery products, nutritional supplements and infant nutrition formulations to adjust taste, stabilize aroma and optimize product texture.
Packing
25kg paper bag with PE inner liner. Customized packing available upon request.
Delivery & Storage
Store in cool, dry and well-ventilated warehouse, keep containers tightly sealed to prevent moisture absorption. Keep away from direct sunlight and high humidity. Shelf life is 24 months under proper storage. Transport as ordinary non-hazardous goods.
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