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