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Pharma grade hydroxypropyl beta cyclodextrin
Fri Feb 9, 2018 08:33
115.192.86.48

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
Identification(LC) 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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