Product Overview & China Production Capacity
Beta-Cyclodextrin (β-CD, CAS 7585-39-9, molecular formula C₄₂H₇₀O₃₅, MW 1134.98) is a cyclic oligosaccharide composed of seven glucose units linked by α-1,4-glycosidic bonds, forming a truncated cone-shaped cavity capable of hosting hydrophobic guest molecules. It is widely used as a solubility enhancer, stabilizer, and inclusion complex agent in pharmaceutical, food, and cosmetic applications. China is a leading global producer of cyclodextrins with annual capacity exceeding 30,000 metric tons from enzymatic starch conversion facilities in Shandong, Henan, and Jiangsu provinces.
In pharmaceutical formulations, beta-cyclodextrin forms inclusion complexes with poorly soluble APIs, improving bioavailability, taste-masking bitter drugs, and enhancing chemical stability of light-sensitive or oxidation-prone compounds. Chinese manufacturers produce beta-cyclodextrin through enzymatic degradation of corn starch using cyclodextrin glucanotransferase (CGTase), followed by selective crystallization to isolate the β-form from α- and γ-cyclodextrin by-products.
Manufacturing Standards & Quality Assurance
Production facilities hold ISO 9001:2015, ISO 22000, and kosher/halal certifications. Quality testing includes assay (HPLC), specific rotation, water content, residue on ignition, reducing sugars, heavy metals, and microbial limits. Products comply with USP/NF, EP, FCC, JP, and ChP monograph specifications. FDA DMF registrations are maintained by major Chinese producers.
Enzymatic conversion conditions (temperature, pH, enzyme dosage, reaction time) are optimized to maximize β-CD yield. Post-enzymatic processing includes heat deactivation, activated carbon treatment, ion exchange, and controlled crystallization. Crystal purity is verified by HPLC to confirm absence of α- and γ-cyclodextrin contamination. Each batch undergoes functional testing for complexation efficiency in addition to standard analytical characterization.
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 7585-39-9 |
| Molecular Formula | C₄₂H₇₀O₃₅ |
| Molecular Weight | 1134.98 g/mol |
| Appearance | White crystalline powder |
| Assay (HPLC, dry basis) | ≥98.0% |
| Specific Rotation [α]D²⁵ | +160° to +164° |
| Water Content | ≤14.0% |
| Reducing Sugars | ≤1.0% |
| Heavy Metals (Pb) | ≤5 ppm |
| Pharmacopoeial Compliance | USP/NF, EP, FCC, JP, ChP |
Packaging & Export Logistics
Beta-cyclodextrin is packed in 25 kg PE-lined fiber drums, palletized for container loading. Smaller packaging (1 kg, 5 kg) is available for R&D customers. Lead time is 10–15 business days. FOB from Shanghai, Qingdao, or Tianjin; CIF and DDP terms supported.
Documentation includes CoA, SDS, DMF reference letter, non-GMO certificate, and commercial shipping paperwork. Non-hazardous classification ensures straightforward international logistics.
China Supply Advantage
China’s abundant corn starch feedstock and advanced enzymatic conversion technology deliver beta-cyclodextrin at 30–45% below Western manufacturer pricing. Integrated starch processing and cyclodextrin production operations ensure supply chain efficiency. Chinese β-CD producers serve pharmaceutical, food encapsulation, and cosmetic companies worldwide with consistent quality and the technical expertise to support inclusion complex development for customer applications.