Product Overview & China Production Capacity
Sucralose (CAS 56038-13-2, molecular formula C₁₂H₁₉Cl₃O₈, MW 397.64) is a non-caloric high-intensity sweetener approximately 600 times sweeter than sucrose, widely used as a taste-masking agent in pharmaceutical formulations and as a sugar substitute in food and beverages. China is the world’s largest sucralose producer, with annual capacity exceeding 15,000 metric tons from production facilities in Anhui, Jiangsu, Shandong, and Hebei provinces, representing over 80% of global production capacity.
In pharmaceutical applications, sucralose provides excellent taste-masking for bitter APIs in oral solutions, suspensions, chewable tablets, and orally disintegrating tablets. Its stability across a wide pH range (2–8), at elevated temperatures, and in the presence of other excipients makes it highly versatile for formulation development. Chinese sucralose manufacturers utilize chlorination of sucrose followed by multi-step purification and crystallization to produce pharma-grade material meeting stringent purity requirements.
Manufacturing Standards & Quality Assurance
Manufacturing facilities hold China ISO 9001:2015, FSSC 22000, and kosher/halal certifications. Quality testing includes assay (HPLC), specific rotation, water content, residue on ignition, related substances, heavy metals, arsenic, chlorinated mono- and disaccharides, methanol, and microbial limits. Products comply with USP/NF, EP, FCC, JECFA, and ChP specifications. FDA DMF registrations support pharmaceutical applications.
Synthesis involves selective chlorination of sucrose at the 4, 1’, and 6’ positions using protecting group chemistry. Multi-step purification includes liquid-liquid extraction, activated carbon treatment, ion exchange, and repeated crystallization. HPLC monitoring at each stage ensures removal of related chlorinated sugar impurities to below specified limits. Final product is dried under vacuum and packaged under controlled humidity conditions.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 56038-13-2 |
| Molecular Formula | C₁₂H₁₉Cl₃O₈ |
| Molecular Weight | 397.64 g/mol |
| Appearance | White crystalline powder |
| Assay (HPLC) | 98.0–102.0% |
| Sweetness Intensity | ~600× sucrose |
| Specific Rotation [α]D²⁰ | +84.0° to +87.5° |
| Water Content | ≤2.0% |
| Heavy Metals (Pb) | ≤1 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, FCC, ChP |
Packaging & Export Logistics
Sucralose is packed in 10 kg or 25 kg PE-lined fiber drums with silica gel desiccant, palletized for container loading. Smaller packaging (1 kg, 5 kg) is available for pharmaceutical R&D and small-batch production. Lead time is 7–12 business days. FOB from Shanghai, Qingdao, or Nanjing; CIF and DDP terms available.
Moisture-protective packaging is essential due to sucralose’s hygroscopic nature. Documentation includes CoA, SDS, kosher/halal certificates, and regulatory compliance dossiers.
China Supply Advantage
As the dominant global sucralose producer, China offers unmatched pricing through scale economies and integrated supply chains from sucrose procurement through finished sweetener packaging. Direct procurement delivers 30–50% savings compared to repackaged material from distributors. Chinese sucralose producers serve major pharmaceutical, food, and beverage companies worldwide with the quality consistency and regulatory documentation required for global market access.