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Betadex Sulfobutyl Ether Sodium Salt CAS No.: 182410-00-0

DMF No.: 030167, CAS No.: 182410-00-0, Betadex Sulfobutyl Ether Sodium Salt is an excipient mainly used in nitrogen-containing drugs. It has special affinity and inclusion properties for nitrogen-containing drugs.

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Product Description

Betadex Sulfobutyl Ether Sodium Salt

AbbreviationSBECD
CAS No.182410-00-0
DMF No.030167
Synonym

Sulfobutylether-beta-Cyclodextrin;

Sulfobutylether-β-Cyclodextrin;

Molecular formulaC42H70-nO35(C4H8O3SNa)n
StandardUSP43-NF38
QualityInjection grade


Description:

Betadex Sulfobutyl Ether Sodium Salt is an anionic bcyclodextrin derivative with a sodium sulfonate salt separated from the hydrophobic cavity by a butyl spacer group. The substituent is introduced at positions 2, 3, and 6 in at least one of the glucopyranose units in the cyclodextrin structure. Introducing the sulfobutylether (SBE) into beta cyclodextrin can produce materials with different degrees of substitution, theoretically from 1 to 21; the hepta-substituted preparation (SBE7-b-CD) is the cyclodextrin with the most desirable drug carrier properties. Betadex Sulfobutyl Ether Sodium Salt occurs as a white amorphous powder.

Betadex Sulfobutyl Ether Sodium salt is an excipient mainly used in nitrogen-containing drugs. It has special affinity and inclusion properties for nitrogen-containing drugs.


Characteristics & Applications:

Betadex Sulfobutyl Ether Sodium Salt is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.The amount of Betadex Sulfobutyl Ether Sodium Salt that may be used is dependent on the purpose for inclusion in the formulation, the route of administration, and the ability of the cyclodextrin to complex with the drug being delivered.

Betadex Sulfobutyl Ether Sodium salt is the sulfonated modified sodium salt of beta cyclodextrin,which is an anionic, highly water-soluble cyclodextrin derivative, can be well incorporated with drug molecules to form non-covalent complexes, thereby improving the stability, water solubility and safety of the drug , reducing nephrotoxicity, ease drug hemolysis, control drug release rate, mask bad odor, etc.

Betadex Sulfobutyl Ether Sodium Salt is derived from beta cyclodextrin, which is nephrotoxic when administered parenterally. However, studies have shown that Betadex Sulfobutyl Ether Sodium Salt is well tolerated at high doses, when administered via intravenous bolus injections, orally, and by inhalation. Up to 9 g/day may be administered by IV infusion in a licensed voriconazole formulation. The safety following high doses of Betadex Sulfobutyl Ether Sodium Salt intravenous administration in humans is continually being investigated.

Betadex Sulfobutyl Ether Sodium Salt has been subjected to an extensive battery of in vitro and in vivo genotoxicity and pharmacological evaluations. No genotoxic or mutagenic changes were observed with Betadex Sulfobutyl Ether Sodium Salt administration. Betadex Sulfobutyl Ether Sodium Salt is biocompatible and exhibits no pharmacological activity. It is rapidly eliminated unmetabolized when administered intravenously.


Administration route:

Injection, oral, nasal, and eye, with special affinity and inclusion properties for nitrogen-containing drugs.


Speciafication:

Please find attached TDS.


Packaging:

Normal package: 10kg/fiber drum


Storage:

Betadex Sulfobutyl Ether Sodium salt is stable in the solid state and should be protected from high humidity. It should be stored in a tightly sealed container in a cool, dry place.


FQA:

1. What is the application category?

Excipients.


2. What is the finished dosage form?

Injection or freeze-dried powder.


3. What are the APIs or compounds associated with it?

Voriconazole, caffezomib, sofibvir, ziprasidone mesylate, maropitam, aripiprazole, posaconazole, carbamazepine, L-phenylalanine nitrogen mustard.


4. What's the main advantanges about your factory?
We have a professional product research and development team, the most advanced production line and detecting instruments, sales team with humanistic service (including after-sale service). Conforms to GMP standand and meets USP42, EP10.


5. How can you ensure the quality you provided ?

We have established a complete procedure to check products at all stages of the manufacturing process-raw materials, process materials, validated or tested materials finished goods etc.. And we have developed a procedure to identify the inspection and test status of all stages of the manufacturing process. We also keep samples for at least 2 years and keep doing stability test.


6. Can purchaser come to audit?
We warmly welcome customers' audit, it's an effective way to build a better business relationship.



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