Product Overview & China Production Capacity
Sodium Starch Glycolate (SSG, CAS 9063-38-1) is a cross-linked sodium carboxymethyl starch derivative that functions as a superdisintegrant in tablet formulations. At concentrations of 2–8%, SSG enables rapid tablet disintegration by swelling 200–300 times its weight upon contact with water, making it essential for immediate-release dosage forms. Chinese manufacturers produce pharma-grade SSG from potato and corn starch feedstocks at production facilities in Shandong, Anhui, and Henan provinces, with combined annual capacity exceeding 15,000 metric tons.
SSG is the most widely used superdisintegrant in global pharmaceutical manufacturing, preferred for its rapid swelling rate, low concentration requirement, and compatibility with a broad range of APIs and excipients. Chinese producers offer multiple grades including Type A (low sodium chloride/sodium glycolate) and Type B (higher sodium levels), each optimized for specific formulation requirements. Advanced cross-linking and carboxymethylation chemistry ensures consistent swelling capacity and disintegration performance across production batches.
Manufacturing Standards & Quality Assurance
Facilities maintain ISO 9001:2015, and cquality certifications. Quality testing includes degree of substitution, pH, loss on drying, sodium chloride, sodium glycolate, heavy metals, iron, settling volume (swelling capacity), and microbial limits. Products comply with USP/NF, EP, JP, and ChP monograph requirements. FDA DMF registrations are maintained by leading Chinese producers.
Manufacturing involves carboxymethylation of starch with sodium chloroacetate, followed by cross-linking to achieve the desired swelling-without-gelling behavior. Process parameters including reaction time, temperature, and cross-linker concentration are precisely controlled. Finished product is washed, dried, and milled to achieve target particle size distribution. Functional testing of swelling volume and disintegration time supplements standard analytical testing.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 9063-38-1 |
| Chemical Name | Sodium Carboxymethyl Starch (cross-linked) |
| Appearance | White to off-white free-flowing powder |
| pH (3.3% suspension) | 5.5–7.5 |
| Loss on Drying | ≤10.0% |
| Sodium Chloride | ≤7.0% (Type A), ≤20.0% (Type B) |
| Sodium Glycolate | ≤2.0% (Type A) |
| Heavy Metals | ≤20 ppm |
| Settling Volume | ≥20 mL/g |
| Pharmacopoeial Compliance | USP/NF, EP, JP, ChP |
Packaging & Export Logistics
SSG is packed in 25 kg PE-lined fiber drums or 25 kg PE-lined kraft bags, palletized and shrink-wrapped. Lead time is 10–15 business days. FOB shipment from Qingdao, Shanghai, or Tianjin ports; CIF and DDP terms available worldwide.
Each shipment includes CoA, SDS, DMF reference letter, and regulatory compliance documentation. Moisture-protective packaging preserves product performance during ocean transit and storage.
China Supply Advantage
Direct SSG procurement from China delivers 25–40% cost savings compared to Western-manufactured alternatives, driven by cost-effective starch feedstocks and efficient manufacturing operations. Chinese SSG producers supply major generic and innovator pharmaceutical companies worldwide, with quality systems validated through customer audits and regulatory inspections. Technical support teams provide formulation development assistance including disintegrant selection guidance and tablet optimization support.