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Hydroxypropyl Beta Cyclodextrin (HP-β-CD) is a hydroxyalkylated derivative of beta-cyclodextrin, produced via controlled substitution of hydroxyl groups with hydroxypropyl moieties. As an injection-grade excipient, this compound functions as a solubilizing agent for poorly water-soluble active pharmaceutical ingredients (APIs). The molecular structure features a hydrophobic internal cavity and a hydrophilic external surface, enabling inclusion complex formation with lipophilic molecules.
This product is manufactured under GMP conditions in a dedicated production facility, with FDA DMF registration (#030168) on file. It complies with USP, EP, and CP monograph specifications, with a betadex residual content of 1.5% maximum and propylene oxide levels below 0.0001%.
Test Item | Specification (USP-NF 2023) |
|---|---|
Appearance | White or almost white, amorphous or crystalline powder. Freely soluble in water and in propylene glycol |
Molar substitution | 0.40-1.50 |
Betadex | ≤1.5% |
Propylene glycol | ≤2.5% |
Any other single impurity | ≤0.25% |
Total impurities (excluding betadex and propylene glycol) | ≤1.0% |
Propylene oxide | ≤0.0001% |
Loss on drying | ≤10.0% |
Clarity of solution | 1.0 g/2 mL water solution is clear and transparent |
Conductivity | ≤200 μS/cm |
Bacterial Endotoxins | ≤10 EU/g |
Total aerobic microbial count | ≤1000 cfu/g |
Total combined molds and yeasts count | ≤100 cfu/g |
Assay | ≥98% |
CAS No. | 128446-35-5 |
Molecular Formula | C42H70-nO35(C3H7O)n |
Molecular Weight | 1134.98 + 58n |
HP-β-CD forms inclusion complexes with lipophilic drug molecules, increasing their aqueous solubility. This property supports formulation development for compounds with low water solubility, enabling liquid dosage form preparation.
By improving drug solubility, HP-β-CD can contribute to enhanced oral bioavailability of certain APIs. Formulators may use this excipient to adjust dosage levels or improve absorption profiles.
The cyclodextrin complex can modulate drug release kinetics. In injection formulations, it may help reduce local irritation or toxicity associated with certain active ingredients.
HP-β-CD is suitable for various delivery routes, including:
Injectable formulations (intravenous, intramuscular)
Mucosal delivery systems (nasal, rectal, ocular)
Transdermal delivery systems
Targeted drug delivery carriers for lipophilic agents
Protein protection and stabilization applications
Manufacturing operations take place in a 2,000 m² dedicated cleanroom facility operated under GMP guidelines. Production processes follow established SOPs with documented batch records.
FDA DMF Registration: #030168
FDA Establishment Identifier (FEI): 3011680310
DUNS Number: 548171477
Facility Address: Boxing Economic Development Zone, Binzhou, Shandong 256500, China
The product meets the requirements of current USP, EP, and CP monographs for Hydroxypropyl Beta Cyclodextrin. Each batch is tested against the specified quality parameters before release.
10 kg per bag
20 kg per bag
Inner packaging: PE bag enclosed in aluminum foil bag
Outer packaging: Carton or fiber drum
Custom labeling available upon request
Shelf life: 36 months in unopened original packaging
Recommended storage: Room temperature, sealed containers, dry conditions
Post-expiry use requires requalification testing for intended application
Inventory levels maintained for standard orders
Lead time: 1-3 working days for stocked items
Shipping terms available: FOB, CFR, CIF, DDU
Loading location: Binzhou, Shandong, China
Air freight and express delivery options available for high-value orders
Yes, sample quantities are available for quality evaluation. Batch production material maintains consistency with sample specifications, verified through batch analysis reports.
Yes, each shipment includes a product analysis report detailing test results against the specified quality parameters. Reports cover all items listed in the product specification.
Pricing varies according to order quantity. Commercial procurement teams may contact the sales department for specific quotation based on required volume and delivery terms.
Standard packaging units are 10 kg and 20 kg. For initial evaluation orders, smaller quantities may be arranged through the sales team. Enterprise customers with specific packaging or formulation requirements should discuss customization options directly.
