pharmaceutical excipient hydroxypropyl-beta-cyclodextrin
Name: hydroxypropyl- beta-cyclodextrin
Other name : hydroxypropyl betadex ; 2-hydroxypropyl-beta-cyclodextirn ;
Hydroxypropyl-β-cyclodextrin .
Abbreviation : HPBCD
CAS: ; 94035-02-6;
EINECS: 420-920-1
Molecular formula : C42H70-nO35(C3H8O2)n
Molecular weight: 1134.98+58n
Solubility(in 100cm3 solvent, at 25℃) : water: >180 g
Methanol: >33g
DMSO: >33g
Qaulity ： Pharma grade / food grade / cosmetics grade / industry grade
Standard : USP38/ EP8.0 / CP2015
Package: 500g/bag , 2kg/bag, 10kg/drum , 20kg/drum
Use : medical food chemical cosmetic other industries
Specification :
ITEMS SPECIFICATION(USP38) RESULTS
Appearance white powder, insipid, innocent Qualify
Assay ≥98％ 99.5%
Degree of Substitution 2.8-10.5 5.5
Clarity of solution 50%(w/v) water solution is clear clear
Identification(IR) same absorption bands with USP Hydroxypropyl Betadex RS Qualify
Loss on Drying ≤10％ 4.5%
Conductivity 10%(w/v) water solution ≤200µS/cm
70
Propylene oxide ≤1ppm ＜0.18ppm
Propylene glycol ≤2.5％ 0.05%
Sum of Other Impurities ≤1％ 0.51%
Betadex ≤1.5% 0.39%
Residue on Ignition ≤0.2％ 0.09%
Heavy Metal ≤20ppm ＜10ppm
chloride ≤0.05% ＜0.05%
Bacterial endotoxins ≤25EU/g <20EU/g
TAMC(cfu/g) ≤1000 80
TYMC(cfu/g) ≤100 30
Salmonella/E. Coli (cfu/g) Absent Absent
Storage: at room temperature, in tightly closed container.
Applications:
Hydroxypropyl-β-cyclodextrin (HP-β-CD) is one of the most widely used cyclodextrin derivatives in current scientific researches and industry applications. It mainly used in food, pharmaceutical and cosmetics industries.
1. In pharmaceuticals industry, HP-β-CD can increase solubility and bioavailability of insoluble drugs, so that the efficacy of drugs can last longer with less ingestion of drugs. It can adjust and control drugs release ratio, decrease side effects of drugs, and enhance stability of drugs. HP-β-CD can be used for oral medication, injection, mucosal delivery systems (including the nasal mucosa, rectum, cornea, etc.), dermal drug delivery systems, lipophilic drugs targeting delivery, and also used as protective agent and stabilizer of protein.
2. In food and perfume industry, HP-β-CD can enhance the stability of nutritional constituent and extend active time of effective constituent. It can cover up bad smell and bad taste of nutritional constituent. It also can improve production processes and product quality.
3. In cosmetics industry, HP-β-CD can reduce stimulate of organic molecular in cosmetic to the skin and mucosa. It can enhance the stability of matter, by preventing oxidation and volatilization of nutrients.
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