PRODUCT TECHNICAL DETAILS
| 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 |
| |
| 2-Hydroxypropyl-β-cyclodextrin Basic information |
| |
| 2-Hydroxypropyl-β-cyclodextrin Chemical Properties |
| Melting point |
278 °C (dec.) |
| refractive index |
125 ° (C=1, H2O) |
| storage temp. |
room temp |
| 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 |
| Provider |
Language |
| SigmaAldrich |
English |
| |
| 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 propylene 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. |
| General Description |
(2-Hydroxypropyl)-β-cyclodextrin, a hydroxyalkyl derivative, finds application as a formulation vehicle that is used to enhance the solubility of the drugs in aqueous solutions for the successful delivery of medical agents to biological systems. It is generally employed as a substitute for α-, β- and γ-cyclodextrins.
|
| 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. |
| |
| 2-Hydroxypropyl-β-cyclodextrin Preparation Products And Raw materials |
|
About US
Leader Biochemical Group is a large leader incorporated industry manufacturers and suppliers of advanced refined raw materials From the year of 1996 when our factory was put into production to year of 2020, our group has successively invested in more than 52 factories with shares and subordinates.We focus on manufacture Pharm & chemicals, functional active ingredients, nutritional Ingredients, health care products, cosmetics, pharmaceutical and refined feed, oil, natural plant ingredients industries to provide top quality of GMP standards products.All the invested factories' product lines cover API and intermediates, vitamins, amino acids, plant extracts, daily chemical products, cosmetics raw materials, nutrition and health care products, food additives, feed additives, essential oil products, fine chemical products and agricultural chemical raw materials And flavors and fragrances. Especially in the field of vitamins, amino acids, pharmaceutical raw materials and cosmetic raw materials, we have more than 20 years of production and sales experience. All products meet the requirements of high international export standards and have been recognized by customers all over the world. Our manufacture basement & R&D center located in National Aerospace Economic & Technical Development Zone Xi`an Shaanxi China. Now not only relying on self-cultivation and development as well as maintains good cooperative relations with many famous research institutes and universities in China. Now, we have closely cooperation with Shanghai Institute of Organic Chemistry of Chinese Academy of Science, Beijing Institute of Material Medical of Chinese Academy of Medical Science, China Pharmaceutical University, Zhejiang University. Closely cooperation with them not only integrating Science and technology resources, but also increasing the R&D speed and improving our R&D power. Offering Powerful Tech supporting Platform for group development. Keep serve the manufacture and the market as the R&D central task, focus on the technical research. Now there are 3 technology R & D platforms including biological extract, microorganism fermentation and chemical synthesis, and can independently research and develop kinds of difficult APIs and pharmaceutical intermediates. With the strong support of China State Institute of Pharmaceutical Industry (hereinafter short for CSIPI), earlier known as Shanghai Institute of Pharmaceutical Industry (SIPI), we have unique advantages in the R & D and industrialization of high-grade, precision and advanced products. Now our Group technical force is abundant, existing staff more that 1000 people, senior professional and technical staff accounted for more than 50% of the total number of employees, including 15 PhD research and development personnel, 5 master′ S degree in technical and management personnel 9 people. We have advanced equipment like fermentation equipment and technology also extraction, isolation, purification, synthesis with rich production experience and strict quality control system, According to the GMP required, quickly transforming the R&D results to industrial production in time, it is our advantages and our products are exported to North and South America, Europe, Middle East, Africa, and other five continents and scale the forefront in the nation, won good international reputation. We believe only good quality can bring good cooperation, quality is our key spirit during our production, we are warmly welcome clients and partner from all over the world contact us for everlasting cooperation, Leader will be your strong, sincere and reliable partner in China.
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