Hydroxypropyl Betadex CAS No. 128446

Basic Info.

Model NO.	BP/USP/FCC
Loading Port	Qingdao
En No.	420-920-1
Delivery	15days
Loading Port 2	Shanghai
M F	C63h112o42
M G	1541.54
Store	Dry and Coold Place
CAS No.	128446-35-5
Transport Package	25kg/Drum
Specification	BP/USP/FCC
Trademark	JK
Origin	China
HS Code	294000
Production Capacity	100mt/Year

Product Description

Hydroxypropyl Betadex is the hydroxyalkylation derivative of Beta Cyclodextrin. Hydroxypropyl Betadex is non-toxic and has no side-effect. Due to its unique structure, it can improve the solubility of drugs, and making the insoluble and the indissolvable drugs dissolved in water. Consequently, it can effectively improve the bioavailability of drugs, and significantly increase the quality of medicine and dosage form. And it is widely used in the development and manufacture of new drugs.

There has been intensive and deep research on the quality, manufacturing process, stability, pharmacology, toxicology, teratogenesis, mutagenesis, carcinogenicity, hemolysis, irritation and other aspects in world, and has obtained accurate evaluation of its safety. It is safe to conclude that derivative of cyclodextrin is the pharmaceutic excipients received the most intensive research, having the most comprehensive information, and having the highest value in medicine excipients.

ASSAY	EP	USP
Appearance	White or almost white, amorphous or crystalline powder	White or almost white, amorphous or crystalline powder
Clarity of solution	See EP9.0	See USP40-NF35
Loss on drying	Maximum 10.0%	NMT 10.0%
Heavy metals		NMT 20μg/g
Betadex	Maximum 1.5%	NMT 1.5%
Propylen glycol	Maximum 2.5%	NMT 2.5%
Any other single impurity		NMT 0.25%
Total impurities excluding betadex and propylen glycol	Maximum 1.0%	NMT 1.0%
Methyl ethylen oxide		NMT 0.0001%
Molar substitution	Molar substitution 0.40-1.50	Molar substitution 0.40-1.50
Conductivity	Maximum 200μA.CM∧-1	Maximum 200μA.CM∧-1

Microbial limit	Corporate internal control standards
The total aerobic microbial count	≤100CFU/g
The total combined molds and yeasts count	≤10CFU/g
Escherichia coli	Not detectable
Bacterial endotoxins	<10IU/g

2-Hydroxypropyl-β-cyclodextrin Basic information

Product Name:	2-Hydroxypropyl-β-cyclodextrin
Synonyms:	Hydroxypropyl beta cyclodextrin aqueous solution;Injection grade hydroxypropyl betadex;Pharmaceutical grade hydroxypropyl betadex;Technical grade hydroxypropyl beta cyclodextrin;HPBCD\/(2-HYDROXYPROPYL)-BETA-CYCLODEXTRIN;beta-hydroxypropylcyclodextrin;(2-HYDROXYPROPYL)-BETA-CYCLODEXTRIN;(2-Hydroxypropyl)-β-cyclodextrin
CAS:	128446-35-5
MF:	C63H112O42
MW:	1541.54
EINECS:	420-920-1
Product Categories:	Biochemistry;Cyclodextrins;Functional Materials;Macrocycles for Host-Guest Chemistry;Oligosaccharides;Sugars;Chelation/Complexation Compounds;Synthetic Reagents;CyclodextrinsCell Culture;CyclodextrinsSynthetic Reagents;Cell Signaling and Neuroscience;Lipids and Lipid Carriers;Reagents and Supplements;Signal Transduction Research Tools;Carbohydrates & Derivatives;Other APIs
Mol File:	128446-35-5.mol

2-Hydroxypropyl-β-cyclodextrin Chemical Properties

Melting point	278 °C (dec.)
refractive index	125 ° (C=1, H2O)
storage temp.	2-8°C
solubility	H2O: 45 % (w/v)
form	solution (clear, colorless)
color	White to slightly yellow
optical activity	[α]26/D +139°, c = 1 in H2O
Water Solubility	Soluble in water.
InChIKey	ODLHGICHYURWBS-FOSILIAISA-N
EPA Substance Registry System	.beta.-Cyclodextrin, 2-hydroxypropyl ethers (128446-35-5)

Safety Information

Safety Statements	24/25
WGK Germany	3
RTECS	GU2293332
TSCA	Yes
HS Code	29400090

2-Hydroxypropyl-β-cyclodextrin Usage And Synthesis

Chemical Properties	White to slightly yellow powder
Chemical Properties	Hydroxypropyl betadex occurs as a white or almost white, amorphous or crystalline powder.
Uses	2-Hydroxypropyl-β-cyclodextrin (HBC) is a widely used modified cyclodextrin, the lipophilic cavity formed by 7 glucose units. Drug solubility in water is greatly enhanced by complexing with 2-Hydroxypropyl-β-cyclodextrin.
Uses	enteric coating, sustained release formulations, buccal and transdermal drug delivery
Uses	2-Hydroxypropyl-β-cyclodextrin can be used as selective estrogen receptor modulator for the prevention of osteoporosis
Production Methods	Hydroxypropyl betadex is prepared by the treatment of an alkaline solution of b-cyclodextrin with oxide. The substitution pattern can be influenced by varying the pH. Formation of O-6 and O-2 substituted products is favored by high and low alkali concentration, respectively. The mixture of products produced may be refined by preparative chromatography.
Pharmaceutical Applications	Hydroxypropyl betadex has been widely investigated in pharmaceutics and has principally been used as a solubilizer for hydrophobic molecules in oral liquids,oral solids, parenterals, pressurized metered dose inhalers, dry powder inhalers, and topical formulations. It has also been shown to act as a stabilizer during processing and storage of formulations.Hydroxypropyl betadex inclusion complexes have been reported to show mechanical properties distinct from the pure materials. The reported advantage of hydroxypropyl betadex over unsubstituted b-cyclodextrin is its greater water solubility.
Safety	The pharmaceutical toxicology of hydroxypropyl betadex has been reviewed, and in general, the material was found to be of low toxicity. It has been suggested that hydroxypropyl betadex may have a synergistic toxic effect with, for example, carcinogens, by increasing their solubility and thus bioavailability.
storage	Store in well-closed containers.
Regulatory Status	Included in oral and parenteral medicinal products. Included in an injectable preparation licensed in the UK for intramuscular or intravenous administration.

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