Product Overview & China Production Capacity
Aspartame (CAS 22839-47-0, molecular formula C₁₄H₁₈N₂O₅, MW 294.30) is a high-intensity artificial sweetener approximately 200 times sweeter than sucrose. In pharmaceutical applications, it serves as a taste-masking agent in chewable tablets, orally disintegrating tablets (ODTs), powder sachets, and oral suspension formulations. It is also widely used in sugar-free cough syrups, effervescent preparations, and pediatric formulations where palatability is critical.
China produces approximately 40,000 MT of aspartame annually, representing over 60% of global production capacity. Our quality-certified manufacturing facility in Jiangsu Province utilizes enzymatic coupling technology for stereoselective synthesis, achieving consistently high optical purity and overall yields that support competitive pharmaceutical-grade pricing.
Manufacturing Standards & Quality Assurance
Our aspartame production follows cpharmaceutical quality guidelines with FSSC 22000, ISO 9001:2015, and HACCP certifications. The product complies with USP/NF, EP, BP, JP, and ChP monographs as well as JECFA and FDA food additive specifications. Production employs an enzymatic synthesis route using thermolysin, followed by crystallization and drying to achieve pharmaceutical-grade purity.
Quality testing includes HPLC assay, specific optical rotation, residual solvents (GC), related substances (5-benzyl-3,6-dioxo-2-piperazineacetic acid and other impurities), arsenic, lead, heavy metals, and microbial limits. Stability studies per ICH guidelines are maintained for ongoing quality monitoring.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder |
| Assay (HPLC, dried basis) | 98.0–102.0% |
| Specific Rotation [α]D²⁰ | +14.5° to +16.5° |
| Loss on Drying | ≤4.5% |
| Residue on Ignition | ≤0.2% |
| Transmittance (1% solution) | ≥95.0% at 430 nm |
| Lead (Pb) | ≤1.0 ppm |
| Arsenic (As) | ≤2 ppm |
| 5-Benzyl-3,6-dioxo-2-piperazineacetic acid | ≤1.5% |
| Other Related Substances | ≤2.0% |
Packaging & Export Logistics
Aspartame is packaged in 25 kg fiber drums with double PE liners, ensuring moisture protection. Custom packaging in 10 kg and 20 kg units is available. Store in a cool, dry place at temperatures below 25°C, protected from light and moisture. Shelf life is 24 months from date of manufacture. The product is non-hazardous for transport purposes.
We ship from Shanghai and Nanjing ports with established routes to all major pharmaceutical markets. Air freight is available for urgent orders. Complete export documentation package includes COA, Halal and Kosher certificates (upon request), and FDA registration numbers.
China Supply Advantage
As the dominant global production base for aspartame, China offers pharmaceutical buyers 40–60% cost savings versus non-Chinese sources. Our enzymatic production process is both cost-efficient and environmentally sustainable, with lower energy consumption and minimal waste compared to conventional chemical synthesis routes.
MOQ is 100 kg for pharmaceutical-grade material. Standard lead time is 7–10 business days with ready stock typically available for immediate shipment. We offer dedicated technical support for taste-masking formulation development and can supply granular grades with improved flowability for direct compression applications. Request your sample today.