Betadex sulfobutyl ether sodium Cas 182410-00-0 COA:
Specification
Items | Specifications | Results |
Appearance (25℃) | White to off-white amorphous powder | White amorphous powder |
Solubility | Freely soluble in water,practically insoluble in anhydrous ethanol and in methylene chloride. | Conforms |
Identification | IR: Same absorption bands | Conforms |
HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution | Conforms |
Sodium: Gives the reactions of sodium | Conforms |
Appearance of solution | Clear and colourless | Conforms |
pH | 5.0~7.5 | 6.6 |
Reducing sugars % | ≤0.05 | 0.01 |
Impurities A % | ≤0.1 | 0.004 |
Impurities C % | ≤0.1 | Absence |
Impurities D% | ≤0.05 | Absence |
Impurities B % | ≤0.5 | 0.020 |
Sodium chloride % | ≤0.2 | ＜0.2 |
Water % | ≤10 | 4 |
TAMC(CFU/g) | ≤102 | 10 |
TYMC(CFU/g) | ≤50 | ＜10 |
Escherichia coli | Absent | Not detected |
Salmonella | Absent | Not detected |
Assay | 95.0%~105.0% | 99.9% |
Average degree of substitution | 5.9~6.6 | 5.9 |
Bacterial endotoxins(EU/mg) | ＜0.02 | ＜0.02 |
Packaging and storage | Preserve in well-closed containers,Protect from moisture. |
Conclusion | The product conforms to the above specifications. |
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Product Name:Betadex sulfobutyl ether sodium
CAS:182410-00-0
MF:C70H119Na7O56S7
Melting point :202-204°C (dec.)
form:Powder
color:White to off-white amorphous
Uses:
Betadex Sulfobutyl Ether Sodium (SBECD)
Product Overview
Betadex Sulfobutyl Ether Sodium (CAS No.: 182410-00-0) is an anionic, high-solubility cyclodextrin derivative. It is primarily used as a solubilizer, stabilizer, and inclusion carrier in pharmaceutical formulations. Its core advantages include significant solubility enhancement, a high safety profile, broad dosage form compatibility, and strong affinity for nitrogen-containing drugs, backed by numerous FDA-approved reference products.
Key Specifications
CAS No.: 182410-00-0
Structure: Sodium salt produced by the sulfobutyl etherification of beta-cyclodextrin with 1,4-butane sultone (average degree of substitution: ~6.2–6.9).
Appearance: White to off-white powder; odorless, slightly sweet taste, and highly soluble in water.
Mechanism: Forms non-covalent inclusion complexes with poorly soluble molecules via its hydrophobic cavity and hydrophilic outer surface, thereby improving solubility, stability, and release profiles.
Commercial References: Captisol is a well-known brand; generic grades such as Dexolve are also available.
Main Applications
Injectable Solubilizer: Enables poorly soluble APIs to reach required concentrations for IV/IM injections.
Oral Bioavailability Enhancer: Improves the dissolution and absorption of oral medications.
Specialized Delivery Systems: Suitable for ophthalmic, nasal, inhalation, and dermal formulations to reduce local irritation and improve compatibility.
Stability & Masking: Protects light/heat/hydrolysis-sensitive APIs and masks bitter tastes or odors.
Controlled Release: Modulates release rates and reduces drug aggregation or precipitation.
R&D Use: Serves as an inclusion carrier, chiral selector, or component in nano-delivery systems.
Key Selling Points
Powerful Solubilization: Can increase API water solubility by 10 to 25,000 times (or higher in some cases).
High Safety Profile: Rapidly eliminated via the kidneys; exhibits lower nephrotoxicity and hemolytic activity compared to natural beta-cyclodextrin.
Broad Compatibility: Versatile for IV, oral, ophthalmic, nasal, inhalation, and topical formulations.
Strong Affinity: Excellent inclusion capability for nitrogen-containing APIs.
Regulatory Acceptance: Proven excipient platform used in multiple FDA-approved products (e.g., VFEND, Geodon, Abilify, Kyprolis, Veklury).
Formulation Flexibility: Can replace traditional solubilizers to simplify formulations and reduce irritation.
Quality Assurance: Available in USP/EP and injectable grades, with suppliers offering DMF/CDE filings and cGMP manufacturing records.
Promotional Highlights
"High-solubility anionic cyclodextrin excipient for injectable and oral APIs."
"Enables formulation of poorly water-soluble drugs with improved stability and bioavailability."
"Renally cleared cyclodextrin derivative with low hemolysis and low irritation."
"Suitable for IV, oral, ophthalmic, nasal, and inhalation formulations."
"Proven excipient platform with multiple FDA-approved reference products."
Note for Inquiries:
When communicating with international clients, it is recommended to specify the Grade, Average Degree of Substitution (DS), Residual Solvents, Bacterial Endotoxins, and DMF/CDE status, as these are the most frequently requested parameters.
Packages
Delivery
Payment term
* Wire Transfer/Telegraphic Transfer
* Western Union
* MoneyGram
* L/C
Also, if you have any other questions, you can contact us
FAQ From Wuhan Fortuna Chemical Co.,Ltd
Q1: Can I get a sample for free ?
A: For small QTY and low value product, we can provide sample for free exclude shipping cost. For high value sample, we will charge the basic sample cost, but we can refund all the cost if customers place order after sample test.
Q2: How to confirm the product quality before placing orders ?
A: Most of our products confirm to international standards like USP/EP/BP/JP/CP. We will provide COA/TDS/MSDS for customers to confirm the specification before placing order.
Q3: What is the payment you accept?
A: For small and low value order, we accept CreditCard, MaterCard,VISA,Western Union and T/T.For large order, we can do T/T and L/C. Any pay on delivery or pay-after are not available for us.
Q4: What is your shipment way ?
A: For less than 100kg gross weight order will ship with courier like FedEx or UPS, we support customers to place courier orders remotely by their account, we will package the goods well and wait for pick up.For more than 100kg goods, we will transport by Air or Sea according to customers' requirement.
Q5: How long is your after-sales service?
A: We accept customer’s quality complaint in three month after customer received the goods. We provide tech.support for all-life if customer place order from our company.
Q6: How do you treat quality complaint ?
A: We support customer to provide our products to any rightful third party testing organization to test our products according to the COA specification, if the test result is confirm with COA, we will take all the loss for customers.
Company Information
Company Information: Wuhan Fortuna Chemical Co.,Ltd established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical and Intermediates, Food and Feed additives, Fine chemicals,Biochemical and Reagent, which is the members of Hubei E-commerce Chamber.
Our company has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement.
We have a positive and self-motivated management work team with a common philosophy, caring and commitment through teamwork, our team strive to achieve success in delighting our clients and ourselves.
Since Wuhan Fortuna Chemical Co., Ltd founded, we continuously innovate our products and improve our service, sales network. Hence, we initiate the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Our products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.We insist on the management creed “Market is our compass, Quality is our life, Credit is our soul”. Clients’ trust is our forward power, their satisfaction is our struggling goal.
Wuhan Fortuna Chemical Co.,Ltd is a professional manufacturer which provide Betadex sulfobutyl ether sodium with good quality and best price, welcome to contact us to get COA/TDS/MSDS of Betadex sulfobutyl ether sodium.
Our Advantages:
1. Guaranteed purity;
2. Large quantity in stock;
3. Largest manufacturer;
4. Best service after shipment with email;
5. High quality & competitive price;
Contact information
Spring Zhang
Email: export@fortunachem.com
Skype: Fortunachem201304
Wechat/Whatsapp: 18007136271
Tel: +86-27-59207892
Website: www.fortunachem.com
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