Specification : USP38

ITEMS

SPECIFICATION

RESULTS

Appearance

White to off-white solid, free from foreign matter

Qualify

Solution Clarity

A 30%w/v solution in water is clear and essentially free from particles of foreign matter

Qualify

Identification (IR)

Consistent with SBECD standard

Qualify

Sodium Identification

Identify test are positive for Sodium

+

Average Degree of Substitution

6.2-6.9

6.7

SBE 1 Content

≤0.2%

0.05%

SBE 2 Content

≤0.8%

0.15%

Water solution pH

pH of 30%w/v solution in water is 4.0-6.8

5.4

Heavy Metals

≤5ppm

<5ppm

Water

≤10%

4.0%

β-Cyclodextrin Content

≤0.1%

Absence

Sodium Chloride

≤0.2%

0.01%

1,4-butane sultone

≤0.5ppm

0.3ppm

4-Hydroxybutane-1-Sulfonic Acid

≤0.09%

0.01%

Disodium bis-(4-sulfobtyl) ether

≤0.05%

0.05%

Assay

95%-105%

99.5%

Bacterial endotoxins

≤25EU/g

≤20EU/g

Microbiology

Total viable aerobic count (mould plus yeast)

≤100CFU/g

20CFU/g

Escherichia Coli

Absence

Absence

Salmonella species

Absence

Absence

mould plus yeast

≤50CFU/g

Absence

Features and applications:

SBE-β-CD is a high water-soluble anionic cyclodextrin derivative. It can easily form non-covalent inclusion complexes with drug molecules, thus it has the good performances in enhancing drug stability, solubility and safety, reducing drug toxicity and hemolysis, covering up bad smell, and controlling drug release rate.

SBE-β-CD has been used in injection, oral, nasal and eye medication. Modification by charged functional units can improve the binding affinity of cyclodextrins for oppositely charged guests, so it has a special affinity for drugs with nitrogen elements.

Shandong Binzhou Zhiyuan biological Technology Co., LTD (Zhiyuan Bio-tech) is a innovative enterprise that is professional in cyclodextrins and their applications. Supported by Shandong University, Zhiyuan Bio-tech has a cyclodextrins research center that located in Jinan.

We have a strong research and development strength of the technical team which hasclose cooperation with Shandong University, Chinese Academy of Science and other world class research institutes. Now we can produce hydroxypropyl cyclodextrin, sulfobutyl ether-beta-cyclodextrin sodium salt, methyl cyclodextrin, mercapto cyclodextrin, amino cyclodextrin, ethanediamine cyclodextrin, piroxicam cyclodextrin, cyclodextrin polymers and other cyclodextrin derivtives. We can also synthesis custom designed cyclodextrin derivatives for your requirements.

Now we have Ion chromatograph (IC), Capillary electrophoresis (CE), High performance liquid chromatograph (HPLC), Gas chromatograph (GC), Fourier transform infrared spectroscopy (FTIR) and other imported advanced testing equipments. Multiple means of analysis and inspection help us ensure production quality and accelerate new production developing.

We are proud of our R&D team that are formed by domestic and overseas experts in the field of cyclodextrin. We believe we can provide first-class products and services for the partners in pharmaceutics, food, cosmetics, pesticides and new materials industries.