Hydroxypropyl Betadex
- 來源: 西安德立生物化工有限公司 作者: admin 時(shí)間: 2022/11/11 14:55:24 點(diǎn)擊率: 69
- 關(guān)鍵詞: Hydroxypropyl Betadex
- 摘要: Hydroxypropyl Betadex is the hydroxyalkylation derivative of Beta Cyclodextrin. Hydroxypropyl Betadex is non-toxic and has no side-effect.
HYDROXYPROPYL BETADEX
Hydroxypropyl Betadex is a hydroxyalkylated derivative of Betadex. Hydroxypropyl Betadex can improve the solubility and bioavailability of some insoluble drugs. Therefore, it can effectively improve the bioavailability of drugs, andcontrol release speed and enhance stability.
[CAS NO]: 128446-35-5
DMF 034772
[Molecular formula]: C42H70O35(C3H6O)x
[Specification]: 500g/Bag; 10kg/Bag.
[Category]: Pharmaceutical excipients
[Storage]: Keep airtight and in a dry place.
[Period of validity]: 36 months
| 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 USP-NF2021, Issue1 |
| Loss on drying | Maximum 10.0% | NMT 10.0% |
| 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% |
| Propylene oxide | / | NMT 0.0001% |
| Molar substitution | 0.40-1.50 | 0.40-1.50 |
| Conductivity | Maximum 200μS.cm-1 | Maximum 200μS.cm-1 |
| Microbial limit | Corporate internal control standards |
| The total aerobic microbial count | ≤10CFU/g |
| The total combined molds and yeasts count | ≤10CFU/g |
| Escherichia coli | Not detectable |
| Bacterial endotoxins | ＜10IU/g |