Product Overview & China Production Capacity
Saccharin Sodium (CAS 128-44-9, molecular formula C₇H₄NNaO₃S·2H₂O, MW 241.19) is a high-intensity artificial sweetener approximately 300–500 times sweeter than sucrose, widely used as a taste-masking agent in pharmaceutical formulations and as a non-caloric sweetener in food and beverage products. China dominates global saccharin production with annual output exceeding 100,000 metric tons, representing over 80% of worldwide capacity. Major production facilities are concentrated in Jiangsu, Shanghai, and Anhui provinces.
In pharmaceutical applications, saccharin sodium masks the bitter taste of APIs in chewable tablets, orally disintegrating tablets, syrups, and oral suspensions. Its excellent stability across a wide pH range and compatibility with most pharmaceutical excipients make it a reliable sweetening agent. Chinese manufacturers produce both dihydrate and anhydrous forms in various particle sizes, meeting USP/NF, EP, FCC, and ChP specifications through the Remsen-Fahlberg or Maumee process synthesis routes.
Manufacturing Standards & Quality Assurance
Production facilities maintain ISO 9001:2015, ISO 22000, FSSC 22000, and China quality certifications. Quality control testing includes assay (HPLC), melting point, loss on drying, heavy metals (ICP), arsenic, selenium, readily carbonizable substances, p-toluenesulfonamide (o-toluene sulfonamide impurity), and microbial limits. All batches comply with USP/NF, EP, FCC, and JECFA specifications.
Synthesis involves toluene sulfonation, oxidation, and cyclization steps with multi-stage crystallization for purification. In-process controls monitor reaction temperatures, oxidation rates, and crystallization conditions. Final product is screened for genotoxic impurity levels below ICH M7 thresholds. Comprehensive batch records ensure full traceability.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 128-44-9 |
| Molecular Formula | C₇H₄NNaO₃S·2H₂O |
| Molecular Weight | 241.19 g/mol |
| Appearance | White crystalline powder |
| Assay | 99.0–101.0% |
| Sweetness Intensity | 300–500× sucrose |
| Loss on Drying | ≤15.0% (dihydrate) |
| Heavy Metals (Pb) | ≤10 ppm |
| p-Toluenesulfonamide | ≤10 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, FCC, ChP |
Packaging & Export Logistics
Saccharin sodium is packed in 25 kg PE-lined fiber drums or 25 kg carton boxes, palletized for container loading. Custom packaging including 1 kg and 5 kg units is available for small-volume pharmaceutical customers. Lead time is 7–10 business days. FOB shipment from Shanghai, Nantong, or Qingdao ports; CIF and DDP delivery terms available.
Documentation includes CoA, SDS, HACCP certification, and regulatory compliance files. Anti-dumping duty considerations for certain markets are addressed through proper documentation and country-of-origin certification.
China Supply Advantage
As the world’s dominant saccharin producer, China offers unmatched pricing through scale economies in toluene-based synthesis and crystallization operations. Direct procurement delivers savings of 30–50% compared to repackaged material from intermediary suppliers. Chinese saccharin producers maintain export relationships with food and pharmaceutical companies in over 100 countries, with quality systems validated by international regulatory inspections and customer audit programs.