Product Overview & China Production Capacity
Anhydrous Calcium Hydrogen Phosphate (Dibasic Calcium Phosphate Anhydrous, CAS 7757-93-9, molecular formula CaHPO₄, MW 136.06) is one of the most widely used direct compression fillers in solid dosage pharmaceutical manufacturing. It provides excellent compressibility, flow characteristics, and tablet hardness, making it the preferred diluent for direct compression formulations of tablets and capsules. It also serves as a calcium and phosphorus source in nutritional supplements.
China is the world’s largest producer of phosphate-based excipients, with annual production capacity exceeding 200,000 MT for pharmaceutical-grade dicalcium phosphate products. Our facility in Hubei Province operates a dedicated anhydrous DCP line with 30,000 MT annual capacity, utilizing high-purity phosphoric acid and calcium carbonate feedstocks for consistent batch-to-batch quality.
Manufacturing Standards & Quality Assurance
Production follows current pharmaceutical quality guidelines with ISO 9001:2015 and ISO 22000 certification. The product meets all specifications outlined in USP/NF, EP, BP, and ChP monographs for Dibasic Calcium Phosphate (Anhydrous). Our in-house quality control laboratory is equipped with XRD for polymorphic confirmation, ICP-MS for trace elemental analysis, and laser diffraction for particle size distribution characterization.
Each batch undergoes 30+ quality parameters testing including assay, loss on ignition, fluoride, arsenic, lead, and microbial limits. We maintain full raw material traceability and support international regulatory submissions with Drug Master File (DMF) documentation available for US FDA, EU ASMF, and other regulatory pathways.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White odorless powder |
| Assay (CaHPO₄, dried basis) | 98.0–105.0% |
| Loss on Ignition | ≤8.5% |
| Fluoride | ≤75 ppm |
| Chloride | ≤0.25% |
| Arsenic (As) | ≤3 ppm |
| Lead (Pb) | ≤5 ppm |
| Heavy Metals | ≤30 ppm |
| Particle Size (D50) | 15–30 µm (unmilled) / customizable |
| Bulk Density | 0.7–1.0 g/mL |
Packaging & Export Logistics
Standard packaging includes 25 kg multiply paper bags with PE inner liner and 500 kg / 1,000 kg bulk bags. Custom packaging configurations are available for OEM customers. Store in a dry environment at ambient temperature (15–25°C); shelf life is 48 months from manufacture date under recommended conditions. The product is classified as non-hazardous for transport under IATA and IMDG codes.
Export shipments depart from Shanghai and Wuhan ports. We provide complete export documentation including COA, MSDS/SDS, and certificates of origin. Transit time to European ports averages 20–28 days; to North American ports 18–25 days via Pacific routes.
China Supply Advantage
Direct direct sourcing of Anhydrous Calcium Hydrogen Phosphate from China delivers 35–50% cost savings compared to European and American excipient producers. Our integrated phosphate chemical complex provides raw material security, while large-scale continuous production ensures competitive unit economics and consistent quality across multi-ton orders.
MOQ is 1,000 kg with standard production lead times of 10–14 business days. Annual supply agreements with quarterly pricing locks are available for committed volumes. Our technical team offers formulation support and can provide custom particle size grades to match your specific tableting requirements. Request a sample and quotation today.