Specification :
| ITEMS | SPECIFICATION(USP39) | 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 | |
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-beta-cyclodextrin 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, hydroxypropyl-beta-cyclodextrin 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. hydroxypropyl-beta-cyclodextrin 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, hydroxypropyl-beta-cyclodextrin 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, hydroxypropyl-beta-cyclodextrin 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.
