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Pharma grade hydroxypropyl beta cyclodextrin

- Apr 14, 2018 -

Name: Pharma grade hydroxypropyl beta cyclodextrin  

Synonym:Pharma grade hydroxypropyl betadex

CAS No.: 128446-35-5

Molecular formula: C42H70-nO35(C3H8O2)n  

Molecular weight: 1134.98+58n

DMF No.: 030168

Standard: USP40-NF35 / CP2015

Qaulity: Pharma grade

Package: 500g/bag,2kg/bag,10kg/drum,20kg/drum 

Molecular structure:

 

Application of hydroxypropyl beta cyclodextrin in pharmaceutical field:

1. To increase the solubility of medicine and biological availability

2. To improve the bio availability of drugs.

3. To adjust or control the releasing of drugs.

4. To decrease the toxicities of drugs.

5. To improve the stabilities of drugs.

Specification :

Standard

 USP40-NF35

ITEMS

SPECIFICATION

 Clarity of Solution

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

Identification (IR)

Same absorption bands as USP betadex sulfobutyl ether sodium RS

 Identification(Sodium)

Identify test are positive for Sodium

IdentificationLC

the retention time of the major peak of  sample solution corresponds to the  standard solution

Average Degree of Substitution

6.2-6.9

Water solution pH

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

Heavy Metals

≤5ppm

Water content

≤10.0%

β-Cyclodextrin Content

≤0.1%

Sodium Chloride

≤0.2%

1,4-butane sultone

≤0.5ppm

4-Hydroxybutane-1-Sulfonic Acid

≤0.09%

Disodium bis-(4-sulfobtyl) ether

≤0.05%

Assay

95.0%-105.0%

Bacterial endotoxins

≤20EU/g

Microbiology

TAMC ( cfu/g)

≤100 cfu/g

TYMC ( cfu/g)

≤50 cfu/g

Escherichia Coli

Absence

Packaging and storage

Preserve in well-closed containers, and store at room temperature. Protect from moisture.

Conclusion: According to USP40-NF35 standard, the product is Qualified.

Storage: at room temperature, in tightly closed container.


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