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Methyl Beta Cyclodextrin (MβCD, CAS 128446-36-6) is a randomly methylated cyclic oligosaccharide composed of seven D-(+)-glucopyranose units. As a derivative of β-cyclodextrin, it features a hydrophobic inner cavity and a hydrophilic outer surface, enabling it to form inclusion complexes with various poorly water-soluble drug molecules. This molecular encapsulation approach represents an established strategy for addressing bioavailability challenges in pharmaceutical formulation development.
The solubilization effect of MβCD stems from its ability to form non-covalent inclusion complexes at a molecular level. When a drug molecule enters the cyclodextrin cavity, the resulting complex exhibits improved aqueous solubility compared to the free drug substance. Methylation of the hydroxyl groups on the cyclodextrin ring further increases water solubility relative to native β-cyclodextrin, with typical solubility exceeding 50 g per 100 mL at 25 °C. This property makes MβCD suitable for a range of formulation approaches where higher drug loading is required.
Parameter | Specification |
|---|---|
Product Name | Methyl Beta Cyclodextrin (MβCD) |
CAS Number | 128446-36-6 |
Molecular Formula | C₄₂H₇₀₋ₙO₃₅·(CH₃)ₙ |
Average Molecular Weight | Approximately 1310 Da |
Degree of Substitution | 10-15 methyl groups per cyclodextrin molecule |
Assay (dry basis) | ≥ 98% |
Purity | ≥ 99% |
Appearance | White, amorphous powder |
Moisture Content | ≤ 5.0% |
pH (5% aqueous solution) | 5.0 - 8.0 |
Heavy Metals | ≤ 10 ppm |
Residue on Ignition | ≤ 0.2% |
Total Aerobic Microbial Count | ≤ 1000 CFU/g |
Grade | Pharmaceutical / Cosmetic / Food |
Quality Standard | Enterprise Standard, compliant with USP/NF reference requirements |
In oral solid and liquid formulations, MβCD assists in improving the dissolution rate and oral bioavailability of BCS Class II and Class IV compounds. It has been applied in formulations of steroid hormones, non-steroidal anti-inflammatory agents, statins, and flavonoid compounds. The inclusion complex can be incorporated into tablets, capsules, oral solutions, and dry powder suspensions.
MβCD is also used in parenteral formulations to solubilize drugs for intravenous, intramuscular, or subcutaneous administration. In topical and ophthalmic formulations, it contributes to enhanced skin and corneal permeation of active ingredients while reducing potential irritation associated with certain drug substances.
Beyond pharmaceutical use, MβCD serves as a functional ingredient in cosmetic formulations, where it acts as a solubilizer for fragrances and active components, helps reduce skin irritation, and supports controlled release of volatile compounds. In food applications, it functions as a stabilizer and flavor encapsulation agent.
The annual production capacity for Methyl Beta Cyclodextrin reaches 50,000 kg, with batch sizes ranging from 50 kg to 2000 kg. Each production batch follows standardized operating procedures to ensure consistent product quality across orders. The manufacturing process takes place in dedicated production facilities located in Shandong, China.
Each batch of MβCD undergoes testing according to established quality control procedures before release. Testing parameters include assay by HPLC, moisture determination, pH measurement, heavy metal analysis, and microbial enumeration. The Quality Assurance department maintains full authority for batch release and material approval. Customers may request a Certificate of Analysis (COA) for each shipment, and third-party audit arrangements can be coordinated upon request.
Methyl Beta Cyclodextrin is supplied in polyethylene inner bags enclosed within aluminum foil bags, with outer packaging available in cartons or fiber drums. Standard packaging sizes include 1 kg, 5 kg, 10 kg, and 25 kg units, with custom labeling and packaging configurations available upon request.
For storage, the material should be kept in well-closed, light-resistant containers in a cool, dry environment with temperatures below 25 °C. Under proper storage conditions, the shelf life is 24 months from the date of manufacture. During handling, standard industrial hygiene practices should be followed, including the use of dust masks in areas where airborne powder may be present.
Our standard Methyl Beta Cyclodextrin has an average degree of substitution ranging from 10 to 15 methyl groups per cyclodextrin molecule. Custom substitution degrees can be developed for specific formulation requirements.
Yes, a Certificate of Analysis (COA) is available for every production batch and can be provided upon request. The COA includes test results for all specified quality parameters, along with batch number, manufacturing date, and expiration date.
The minimum order quantity is 1 kg for standard pharmaceutical grade MβCD. Larger volume orders receive volume-based pricing. Samples are available for evaluation purposes before placing full orders.
Yes, custom synthesis services are available for clients requiring specific degrees of substitution or specialized methylation patterns. Technical consultation regarding formulation compatibility is provided by experienced technical staff.
Standard orders typically ship within 1-3 working days for in-stock items. Custom specifications may require additional production time, which will be confirmed at the time of order placement. Multiple shipping methods and payment terms are available to accommodate different commercial procurement requirements.