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 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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