Description
The water-free form of lactose, used as a direct-compression filler-diluent where moisture sensitivity of the API or formulation rules out the monohydrate. Particularly valuable in moisture-sensitive solid-dose tablets, dry powder inhaler carrier blends that require low residual water, and effervescent or hygroscopic API systems.
White to off-white crystalline or amorphous powder, slightly sweet, freely soluble in water, practically insoluble in alcohol. Contains essentially no water of crystallization, with loss on drying typically below 1.0 percent against the monograph limit.
We supply pharmaceutical-grade Lactose Anhydrous from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production. The pharmaceutical anhydrous lactose monograph requires segregated production lines, full BSE/TSE source documentation, and allergen control documentation against the dairy supply.
Common market grades include direct-compression anhydrous beta-lactose (the dominant DC grade, with high beta-lactose fraction for improved compressibility), milled anhydrous alpha-lactose (for capsule blends and dry powder inhaler carriers), and roller-compacted anhydrous grades for high-throughput tablet presses.
Bulk and reduced-MOQ shipments. Batch-level COA covering identification, assay, specific rotation, loss on drying, particle size distribution, microbiology, and full source documentation against USP, EP, JP, and BP monographs.
Introduction
Anhydrous Lactose is the water-free crystalline form of lactose and the principal alternative to the monohydrate in moisture-sensitive pharmaceutical formulations. It has been used in solid-dose manufacturing since the mid-twentieth century and gained particular importance with the rise of direct-compression tablet processes that required improved-flow, low-moisture fillers.
Production proceeds by crystallizing lactose from a supersaturated dairy whey or permeate solution at temperatures above 93.5 degrees Celsius, the transition temperature above which the anhydrous beta-lactose form crystallizes preferentially. The product is washed, dried, and milled or roller-compacted to defined particle size and bulk density.
Listed in USP-NF, EP, JP, and BP monographs. Pharmaceutical-grade anhydrous lactose is fully segregated from food-grade production and requires dedicated manufacturing lines, BSE/TSE source statements covering the dairy supply, and full residual protein and microbiology control to monograph limits.
The principal formulation advantage over the monohydrate is loss on drying typically below 1 percent, which protects moisture-sensitive APIs (aspirin, hygroscopic salts, primary-amine actives) from hydrolysis during shelf life. The principal disadvantage is somewhat higher cost and slightly more limited supply.
Strategic position: the default filler choice for direct-compression tablets containing moisture-sensitive APIs, and a standard carrier in dry powder inhaler formulations.
Where it is used
- Direct-compression filler for moisture-sensitive APIs
- Carrier for hygroscopic actives in solid-dose tablets
- Diluent in effervescent tablet formulations
- Carrier in dry powder inhaler blends requiring low residual water
- Filler in chewable and orally disintegrating tablets
- Capsule diluent for moisture-sensitive capsule formulations
- Carrier for low-dose APIs and potent active blends
- Diluent in lyophilized cake formulations
Technical data
| Item | Specification |
|---|---|
| Appearance | White or almost white crystalline or amorphous powder |
| Compliance | USP/NF, EP, JP, BP current edition |
| Identification | Conforms to pharmacopoeial tests |
| Assay (lactose, dried basis) | ≥ 99.0% |
| Specific rotation | +54.4° to +55.9° (anhydrous basis) |
| Loss on drying | ≤ 1.0% |
| Sulfated ash | ≤ 0.1% |
| Protein and light-absorbing impurities | Passes test |
| Acidity or alkalinity | Passes test |
| Beta-lactose content (DC grade) | ≥ 70% |
| Heavy metals (as Pb) | ≤ 5 mg/kg |
| Bulk density (DC grade) | 0.60 to 0.80 g/mL |
| Particle size | Per grade specification (DC, milled, or inhalation) |
| Total aerobic count | ≤ 100 CFU/g |
| Yeast and mould | ≤ 50 CFU/g |
| E. coli, Salmonella | Absent |
| BSE/TSE | Free, supported by source documentation |
| Source | Bovine milk whey or permeate, segregated pharmaceutical line |
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