Product Overview & China Production Capacity
Lactose Monohydrate (CAS 64044-51-5, molecular formula C₁₂H₂₂O₁₁·H₂O, MW 360.31) is the most widely used filler-diluent in pharmaceutical tablet and capsule manufacturing worldwide. It provides excellent compressibility, flow characteristics, and chemical compatibility with most active pharmaceutical ingredients. Pharmaceutical-grade lactose is available in multiple functional forms including crystalline, spray-dried, granulated, and milled grades, each optimized for specific manufacturing processes — direct compression, wet granulation, dry granulation, or dry powder inhalation.
China has developed significant pharmaceutical lactose capacity, with annual production exceeding 80,000 MT. Our dairy-pharmaceutical facility in Inner Mongolia uses fresh bovine whey and milk permeate from local dairy operations, crystallizing and processing pharmaceutical-grade lactose monohydrate at 15,000 MT/year capacity. Our location in China’s premier dairy region ensures consistent, high-quality raw material supply.
Manufacturing Standards & Quality Assurance
Production is quality-certified with ISO 9001:2015 and FSSC 22000 quality systems. The product meets USP/NF, EP, BP, JP, and ChP monograph specifications for Lactose Monohydrate. We maintain US FDA DMF registrations and EDQM CEP (Certificate of European Pharmacopoeia suitability) for European market access. BSE/TSE risk assessment documentation per EMEA/410/01 guidelines is provided.
Quality control includes optical rotation, loss on drying, clarity and color of solution, acidity, protein content, heavy metals, and comprehensive microbial testing including Salmonella absence. For inhalation grades, additional testing covers particle size distribution (laser diffraction and cascade impaction), fine particle fraction, and surface energy characterization. All lactose is from bovine milk origin with full traceability.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Assay (on dried basis) | 99.0–101.0% |
| Specific Rotation [α]D²⁰ | +54.4° to +55.9° |
| Loss on Drying (80°C, 2h) | ≤0.5% (anhydrous) / 4.5–5.5% (monohydrate) |
| Acidity | ≤0.4 mL 0.1N NaOH |
| Protein (Kjeldahl) | ≤0.1% |
| Heavy Metals (as Pb) | ≤5 ppm |
| Sulfated Ash | ≤0.1% |
| Particle Size | Grade-specific (see product range) |
Packaging & Export Logistics
Supplied in 25 kg multiply paper bags with PE inner liner or 25 kg fiber drums (for inhalation grades). Bulk packaging in 500 kg and 1,000 kg FIBCs is available for standard grades. Store in a dry environment at 15–25°C, protected from moisture and strong odors. Shelf life is 48 months. Non-hazardous for transport. Container loading: 20–24 MT per 20′ FCL.
We export from Tianjin and Shanghai ports with cold-chain logistics available for temperature-sensitive grades. Complete documentation includes COA, MSDS, DMF reference letters, CEP copies, BSE/TSE declaration, and Halal/Kosher certificates.
China Supply Advantage
Chinese pharmaceutical-grade lactose has achieved quality parity with established European producers while offering 30–45% cost advantages. Our Inner Mongolia facility benefits from low-cost dairy whey supply, efficient processing infrastructure, and competitive operating costs — making high-quality pharmaceutical lactose accessible to cost-conscious formulators worldwide.
MOQ is 1,000 kg with 10–14 business day lead times. We offer a complete pharmaceutical lactose portfolio including regular crystalline, spray-dried (for direct compression), granulated, sieved, and milled grades. Technical data packages with compaction profiles, flow property data, and dissolution compatibility studies are available. Contact us for grade selection assistance and competitive pricing.