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This pharmaceutical-grade alpha cyclodextrin powder is manufactured in a GMP-compliant production facility, developed for critical drug delivery applications in the pharmaceutical sector. The product features a defined cavity structure that supports targeted small molecule inclusion complexation, with established effects on enhancing formulation stability, inhibiting oxidative degradation, and masking unpleasant odors. The production management system is certified under ISO 9001, and a full Certificate of Analysis (COA) is provided for every production batch to support quality verification for commercial procurement. It serves as a functional excipient for formulation development and production across various small molecule pharmaceutical dosage forms.
Alpha cyclodextrin is a cyclic oligosaccharide with a characteristic torus-shaped molecular structure. Its outer rim exhibits hydrophilic properties, while the internal cavity presents a hydrophobic environment. This unique structural feature allows cyclodextrin to act as a host molecule, enclosing a variety of suitable guest substances including organic molecules, inorganic ions, and gas molecules. This inclusion capability has led to its broad adoption across catalysis, separation technology, food processing, and pharmaceutical manufacturing fields.
Beyond the general functional properties shared across the cyclodextrin family, alpha cyclodextrin has a smaller internal cavity diameter compared with beta-cyclodextrin. This structural difference makes it particularly suitable for inclusion complexation with small molecule substances, as well as for formulation scenarios that require high solubility of the cyclodextrin component. This specificity supports precise formulation design in small molecule drug development and production processes.
Name | Alpha cyclodextrin (α-CDE) |
|---|---|
CAS Number | 10016-20-3 |
Molecular Formula | C36H60O30 |
Molecular Weight | 97 2.84 |
Appearance | White or almost white, amorphous or crystalline powder |
Assay | ≥99％ |
Classification | Pharmaceutical Grade |
Name | Alpha cyclodextrin (α-CD) |
|---|---|
ITEMS | CRITERIA |
Appearance | White or almost white, amorphous or crystalline powder |
Residue on Ignition | ≤0. 1% |
Limit of Light-absorbing Substances | Between 230nm- 350nm, absorbance is NMT 0. 10; between 350nm-750nm, absorbance is NMT 0.05. |
Reducing Sugars | ≤ 0.2% |
PH | 5.0-8.0 |
Water determination | ≤ 11.0 ％ |
Assay | 98.0% - 101.0% |
The total aerobic microbial count | ≤ 1000cfu/g |
The total combined moulds and yeasts count | ≤ 100cfu/g |
Alpha cyclodextrin serves multiple functional roles in pharmaceutical development and production. First, it can increase the chemical stability of active pharmaceutical ingredients (APIs) by isolating guest molecules from external environmental factors such as light, moisture and reactive media. Second, the sealed inclusion structure can prevent oxidative decomposition of drug molecules, reducing degradation during production, storage and transportation, and extending the shelf life of finished formulations.
Third, alpha cyclodextrin can improve the aqueous solubility of poorly soluble small molecule drugs, thereby supporting higher bioavailability after administration. Fourth, the inclusion complex can reduce the local irritation and adverse reactions associated with certain drug substances, improving patient tolerance. Fifth, the cavity structure can encapsulate odor-causing components, masking unpleasant odors or tastes in oral dosage forms.
This product is applicable to various small molecule drug formulation development processes, supporting different drug delivery system designs for industrial applications.
The product is packaged in standard industrial drums, with a net content of 25kg per drum. Packaging specifications can be discussed for custom bulk commercial orders.
The product should be preserved in tight containers. No additional special storage requirements are specified under normal ambient storage conditions.
The product is maintained in regular stock for standard orders. Delivery is arranged within 1-3 workdays after order confirmation for in-stock items.
The basic product profile lists a minimum assay of 99%, while the detailed quality specification defines an assay range of 98.0% - 101.0%. All batches are tested according to standardized quality protocols, and full COA documentation with complete test results is available for every batch for formal quality verification.
With its smaller internal cavity, alpha cyclodextrin is optimized for inclusion complexation with small molecule APIs. It is widely used in oral solid dosage forms, topical preparations, and other drug delivery systems that require stability enhancement, solubility improvement, taste masking or odor masking.
This alpha cyclodextrin powder is produced in a GMP-compliant manufacturing facility, and the production management system holds ISO 9001 certification. All quality control processes follow standardized testing protocols to ensure consistent batch-to-batch quality and full traceability.
