Product Overview & China Production Capacity
Pregelatinized Starch (CAS 68412-29-3) is a physically modified starch produced by cooking and drum-drying or spray-drying native starch to create a cold-water-soluble, directly compressible excipient. It functions simultaneously as a binder, filler, and disintegrant in tablet formulations, making it one of the most versatile pharmaceutical excipients available. Chinese manufacturers operate large-scale drum-drying and spray-drying facilities processing corn and potato starch feedstocks, with combined annual pharma-grade output exceeding 20,000 metric tons from facilities in Shandong, Jilin, and Inner Mongolia.
Pregelatinized starch enables direct compression tableting without the need for wet granulation, reducing processing steps and manufacturing costs. It provides moderate binding strength with rapid disintegration, making it ideal for immediate-release tablet formulations. Partially pregelatinized grades offer a controlled ratio of swelling and soluble fractions, allowing formulators to fine-tune tablet hardness and disintegration time. Chinese producers offer multiple grades with varying degrees of pregelatinization to meet diverse formulation requirements.
Manufacturing Standards & Quality Assurance
Facilities hold ISO 9001:2015, and FSSC 22000 certifications. Testing protocols cover loss on drying, pH, residue on ignition, protein content, sulfur dioxide, heavy metals, microbial limits, and cold-water-soluble fraction percentage. Products comply with USP/NF, EP, and ChP monograph requirements. Non-GMO corn starch feedstock is available for markets requiring non-GM certification.
Processing parameters including drum temperature, gap thickness, rotation speed, and moisture content are monitored continuously to ensure consistent pregelatinization degree. Finished product particle size distribution is controlled through milling and sieving to achieve target flowability and compressibility characteristics. Each batch undergoes compressibility and disintegration functional testing in addition to pharmacopoeial analytical testing.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 68412-29-3 |
| Source Material | Corn starch (non-GMO available) |
| Appearance | White to off-white powder |
| Loss on Drying | ≤14.0% |
| pH (10% slurry) | 4.5–7.0 |
| Cold Water Soluble Fraction | 10–20% (partially pregelatinized) |
| Protein Content | ≤0.5% |
| Sulfur Dioxide | ≤50 ppm |
| Heavy Metals | ≤10 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, ChP |
Packaging & Export Logistics
Pregelatinized starch is packed in 25 kg PE-lined multiply kraft bags, palletized and stretch-wrapped. Bulk 500 kg or 1,000 kg FIBCs are available for large orders. All packaging meets food-contact material regulations. Lead time is 10–15 business days. FOB shipment from Qingdao, Shanghai, or Tianjin ports; CIF and DDP delivery available worldwide.
Documentation includes CoA, SDS, non-GMO certificate (upon request), and commercial shipping paperwork. Temperature and humidity controlled storage recommendations are provided for tropical climate destinations.
China Supply Advantage
China’s corn belt in northeastern provinces provides abundant, cost-effective starch feedstock for pregelatinized starch production. Direct procurement delivers 20–35% savings compared to Western-manufactured equivalents. Chinese producers supply major pharmaceutical companies worldwide with consistent batch-to-batch quality verified through functional testing beyond basic pharmacopoeial requirements. Responsive technical teams support formulation optimization and scale-up activities for customers developing new tablet products.