Hydroxypropyl Beta Cyclodextrin CAS No. 128446

Basic Info.

Model NO.	BP/USP/FCC
M F	C63h112o42
En No.	420-920-1
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%
Propyne glycol	Maximum 2.5%	NMT 2.5%
Any other single impurity		NMT 0.25%
Total impurities excluding betadex and prolene glycol	Maximum 1.0%	NMT 1.0%
Methyl ethylnexide		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

Natural Cyclodextrin;
Alpha-Cyclodextrin	Beta-Cyclodextrin		Gamma-Cyclodextrin
Alpha Cyclodextrin Derivatives;
Hydroxypropyl-Alpha-Cyclodextrin		Sulfobutylether-Alpha-Cyclodextrin
Beta Cyclodextrin Derivatives;
Hydroxypropyl-Beta-Cyclodextrin		Sulfobutyl ether-Beta-Cyclodextrin Sodium
Piroxicam-Beta-Cyclodextrin		Glucosyl-Beta-Cyclodextrin
Hydroxyethyl-Beta-Cyclodextrin		Carboxymethyl-Beta-Cyclodextrin
Hydroxypropyl-Beta-Cyclodextrin		2,6-Dimethyl-Beta-Cyclodextrin
2-Hydroxypropyl-Beta-Cyclodextrin		Methyl-Beta-Cyclodextrin
Gamma Cyclodextrin Derivatives;
Hydroxypropyl-Gamma-Cyclodextrin		Sulfobutylether-Gamma-Cyclodextrin
Cyclodextrin Inclusion Compounds
Soluble inclusion compound of pueraria flavones		Soluble inclusion compound of Gynostemma Extract
Plant essential oil inclusion compound		Flavor inclusion compound
Rotation substance separation reagent
Chromatogram filler: cyclodextrins.

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 propene 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.

Hunan JK International Trade Corporation / JK BIO-CHEM CO.,LTD is a professional exporter of food/feed additives and food /feed ingredients in China. With years of development, now we are able to provide the following food additives and food ingredients: thickeners, antioxidants, preservatives, vitamins, sweeteners, proteins, acidulants, nutritional supplements, flavours, coenzyme and so on.
Our food additives and food ingredients, especially our Ascorbic Acid (Vitamin C), Acesulfame-K, Aspartame, Citrates, Dextrose, D-Xylose, Erythorbic Acid, Fumaric Acid, Fructose,Maltodextrin, Malic Acid, Monosodium glutamate, Lactic Acid Potassium Sorbate, Sodium Erythorbate, Sodium Cyclamate, Sodium Saccharin, sodium benzoate, Sodium ascorbate, Sorbic Acid, xanthan Gum, Xylitol, Tartaric Acid, I+G, , Vanillin, Sucralose, Stevia and so on, have been exported to more than 60 countries for our good quality products.
Our staff of sales and technical support is available to help you in selecting the right protection for your application as well as to provide you with samples of our products for evaluation. At High Five, we are committed to providing the highest level of customer service, competitive pricing, speedy delivery and a comprehensive, cutting-edge product offering. Our ultimate goal is your satisfaction.

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