• Company Introduction

    Xi’an DELI  Biochemical  Industry Co., Ltd. was established in  August 1999. The company is located  in Daixin  Industrial Park  at  the  foot  of  Lishan  Mountain.  It covers  an area of about 14000  square  meters and is  a  modern  pharmaceutical  excipients manufacturer of integrating research  and  development,  production  and  sales.  The  company  independently  developed Hydroxypropyl  Beta  Cyclodextrin,  Betadex  Sulfobutyl  Ether  Sodium  and  other  kinds  of cyclodextrin  excipients.  We  are  the  first  enterprise  to  be  approved by the State Food  and Drug  Administration  who  can  produce  the  injection   grade Hydroxypropyl  Beta Cyclodextrin in  China. The company  quality management  system has  passed   IS09001:2015  certification. The company  now has  a  high  standard production workshop of 1000  square meters, inspection equipment  includes:  Waters  HPLC  System,  Agilent  gas  chromatograph,  Acidity  meter, Infrared  spectromete rAB SCIEX Capillary electrophoresis system and so on, our company can meet the testing requirements of all projects  in  each production link. The products are stable and exported to  Asia, Africa, Europe and America. Our company also has been rated as a high and new technology enterprise for many years.




Betadex Sulfobutyl Ether Sodium

CAS: 182410-00-0

DMF: 034773

Betadex Sulfobutyl Ether Sodium is a sodium salt produced when betacyclodextrin is alkylated by 1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble betacyclodextrin derivative. Betadex Sulfobutyl Ether Sodium is can be well combined with the drug molecules to form non-covalent complex, thereby enhancing the stability, water solubility, and safety of the drug, reducing its renal toxicity, easing drug hemolysis, controlling drug release rate, covering bad smell, etc. Compared with betacyclodextrin, sulfobutyl betacyclodextrin sodium has a higher water solubility, smaller hemolytic effect, and lower renal toxicity, which make it a new pharmaceutical excipient with very broad application prospects.

Betadex Sulfobutyl Ether Sodium (USP-NF2021,Issue 1)

ASSAY

SPECIFICATION

【IDENTIFICATION】

A Infraredabsorption

Complies with SBECD reference

B Content Analysis

tR of the major peak complies with SBECD  reference

C Average Degree of Substitution.

meets the requirements of the test for Average Degree of Substitution.

D GENERAL,Sodium

Positive test for sodium

【ASSAY】

THE PERCENTAGE OF BETADEX SULFOBUTYL ETHER SODIUM

95.0%-105.0%

【IMPURITIES】

LIMIT OF BETADEX

NMT 0.1%

LIMIT OF 1,4-BUTANE SULTONE

NMT 0. 5ppm

LIMIT OF SODIUM CHLORIDE,4-HYDROXYBUTANE-1-SULFONIC ACID,AND BIS(4-SULFOBUTYL) ETHER DISODIUM

Sodium chloride

NMT 0.2%

4-Hydroxybutane-1-sulfonic acid

NMT 0. 09%

(4-sulfobutyl) disodium

NMT 0. 05%

【SPECIFIC TESTS】

BACTERIAL ENDOTOXINS TEST

10EU/g

Microbial Enumeration Tests

The total aerobic microbial count

NMT 100cfu/g

The total combined molds and yeasts count

NMT 50cfu/g

Tests for Specified Microorganisms

Absence of Escherichia Coli/1g

Clarity of Solution(30%,w/v)

The solution is clear ,and essentially free from particles of foreign matter

AVERAGE DEGREE OF SUBSTITUTION

6.2-6.9

Ether Sodium Peaks I -X

Limit Range(%Peak Area)

I

0-0.3

II

0-0.9

III

0.5-5.0

IV

2.0-10.0

V

10.0-20.0

VI

15.0-25.0

20.0-30.0

10.0-25.0

2.0-12.0

0-4.0

PH

4.0-6.8

WATERDETERMINATION

NMT10%


Betadex Sulfobutyl Ether Sodium

CAS: 182410-00-0

DMF: 034773

Betadex Sulfobutyl Ether Sodium is a sodium salt produced when betacyclodextrin is alkylated by 1,4-butanesulfonic acid lactone under alkaline conditions. It is an anion, highly water-soluble betacyclodextrin derivative. Betadex Sulfobutyl Ether Sodium is can be well combined with the drug molecules to form non-covalent complex, thereby enhancing the stability, water solubility, and safety of the drug, reducing its renal toxicity, easing drug hemolysis, controlling drug release rate, covering bad smell, etc. Compared with betacyclodextrin, sulfobutyl betacyclodextrin sodium has a higher water solubility, smaller hemolytic effect, and lower renal toxicity, which make it a new pharmaceutical excipient with very broad application prospects.

Betadex Sulfobutyl Ether Sodium ( EP10.0)
【CONTENT】
SULFOBUTYLBETADEX SODIUM 95.0%-105.0%
AVERAGE DEGREE OF SUBSTITUTION 5.9-6.6
【CHARACTERS】
APPEARANCE white or almost white, hygroscopic powder
SOLUBILITY freely soluble in water, practically insoluble in anhydrous ethanol and in methylene chloride
【IDENTIFICATION】
A INFRAED ABSORPTION SPECTROPHOTOMETRY

Complies with SBECD referance

B SODIUM REACTION

Positive test for sodium

【TEST】
PH 5.0-7.5
APPEARANCE OF SOLUTION

The solution is clear and colourless

REDUCING SUGARS NMT 0.05%
【IMPURITIES】
Limit of betadex NMT 0.1%
Limit of 1'2λ6-oxathiane-2,2-dione NMT 0. 5ppm
Limit of 4-hydroxybutane-1-sulfonic acid NMT 0. 1%
Limit of 4,4'-oxydi(butane-1-sulfonic acid) NMT 0. 05%
LIMIT OF SODIUM CHLORIDE NMT 0.12%
WATER NMT10.0%
【MICROBIAL CONTAMINATION】
the total aerobic microbial count NMT 100cfu/g
the total combined molds and yeasts count NMT 100cfu/g
Escherichia coli. absence
Salmonella absence


HYDROXYPROPYL BETADEX

CAS: 128446-35-5

DMF: 0347732

Hydroxypropyl Betadex is the hydroxyalkylation derivative of Beta Cyclodextrin. Hydroxypropyl Betadex is non-toxic and has no side-effect. Due to its unique structure, it can improve the solubility of drugs, and making the insoluble and the indissolvable drugs dissolved in water. Consequently, it can effectively improve the bioavailability of drugs, and significantly increase the quality of medicine and dosage form. And it is widely used in the development and manufacture of new drugs.

There has been intensive and deep research on the quality, manufacturing process, stability, pharmacology, toxicology, teratogenesis, mutagenesis, carcinogenicity, hemolysis, irritation and other aspects in world, and has obtained accurate evaluation of its safety. It is safe to conclude that derivative of cyclodextrin is the pharmaceutic excipients received the most intensive research, having the most comprehensive information, and having the highest value in medicine excipients.

ASSAY EP USP
Appearance White or almost white, amorphous or crystalline powder White or almost white, amorphous or crystalline powder
Clarity of solution See EP10.0 See USP43-NF38
Loss on drying Maximum 10.0% NMT 10.0%
Heavy metals NMT 20μg/g
Betadex Maximum 1.5% NMT 1.5%
Propylene glycol Maximum 2.5% NMT 2.5%
Any other single impurity NMT 0.25%
Total impurities excluding betadex and propylene glycol Maximum 1.0% NMT 1.0%
Methyl ethylene oxide NMT 0.0001%
Molar substitution Molar substitution 0.40-1.50 Molar substitution 0.40-1.50
Conductivity Maximum 200μA.CM∧-1 Maximum 200μA.CM∧-1
Microbial limit Corporate internal control standards
The total aerobic microbial count ≤100CFU/g
The total combined molds and yeasts count ≤10CFU/g
Escherichia coli Not detectable
Bacterial endotoxins <10IU/g


Xi'an DELI Biochemical Industry Co.,Ltd.

Tel:+86-29 87860211

E-mail:xadl@xadl.com

Add:9 Lifeng road, Daixin Industrial Park Lintong District Xi'an, Shaanxi Province, China