Shaanxi Yuantai Biological Technology Co., Ltd. is one of the most reliable manufacturers and suppliers of hydroxypropyl beta cyclodextrin in China. With abundant experience, we warmly welcome you to wholesale bulk hydroxypropyl beta cyclodextrin for sale here from our factory. Quality products and reasonable price are available.
What is Hydroxypropyl-β-cyclodextrin?
Hydroxypropyl-β-cyclodextrin(Hydroxypropyl Beta Cyclodextrin) is a highly water-soluble derivative of β-cyclodextrin obtained through hydroxypropylation modification. It appears as a white to off-white crystalline powder. The presence of the hydroxypropyl group significantly enhances its solubility in water while retaining its ability to encapsulate lipid-soluble molecules.
As a mature pharmaceutical excipient and functional carrier, hydroxypropyl-β-cyclodextrin, through inclusion technology, can significantly improve the solubility and stability of poorly soluble components, achieving multiple effects such as solubilization, taste masking, controlled release, and irritation reduction. It is widely used in oral formulations, transdermal drug delivery systems, food, and cosmetics.
YTBIO supplies high quality hydroxypropyl-β-cyclodextrin, characterized by high purity, good solubility, and strong batch stability. We support small-batch sample testing and large-volume orders, providing complete compliance documentation with each shipment.
COA OF Hydroxypropyl Beta Cyclodextrin:
| ITEM | STANDARD | TEST RESULT |
|---|---|---|
| Hydroxypropoxy | 19.6%–26.3% | 25.3% |
| Cyclodextrin | ≤0.5% | 0.26% |
| Physical & Chemical | ||
| Appearance | White powder | White crystal powder |
| pH | 5.0–7.5 | 6.4 |
| Chloride | ≤0.05% | 0.02% |
| 1,2-Propanediol | ≤0.5% | Negative |
| Loss on Drying | ≤6.0% | 3.8% |
| Ash | ≤0.2% | 0.04% |
| Heavy Metal | ||
| Total Heavy Metals | ≤10ppm | <5ppm |
| Microbiological Test | ||
| Total Plate Count | ≤100cfu/g | <10cfu/g |
| Mold and Yeast | ≤100cfu/g | <10cfu/g |
| E.Coli | Negative | Negative |
| Salmonella | Negative | Negative |
| Staphylococcus | Negative | Negative |
| Conclusion | Conform with specification | |
| Storage | Store in cool and dry places. Keep away from strong light and heat | |
| Packing | By 25kgs/Drum, inner by double plastic bag | |
| Shelf Life | 24 months under the above condition, and in its original package |
Characteristics and safety
Characteristics
- High water solubility: The solubility is more than 50% (w/v) at room temperature, and it cannot crystallize in alcohol-water solution, making it easy to use in preparations.
- Selective inclusion ability: Compared with natural β-cyclodextrin (β-CD), HP-β-CD may have different inclusion ratios and selectivity for certain substances, affecting drug release and stability.
- Metabolic inertness: After oral administration, it is basically not absorbed by the intestine and excreted with feces; after parenteral administration (such as intravenous injection), it is almost completely excreted through urine, without the risk of accumulation in the body.
- Promote drug release: It can quickly release the encapsulated drug molecules in the body and improve bioavailability.
- Low surface activity and hemolysis: Compared with β-CD and its methylated derivatives, HP-β-CD has lower surface activity and hemolysis activity and better safety.
Safety
Animal experiments:
- Subacute and chronic toxicity studies have shown that HP-β-CD does not cause disease or death in mice.
- After intravenous injection in rabbits, it was rapidly cleared and there were no adverse reactions after continuous administration.
- No clinical abnormalities were observed in mice and monkeys after intravenous injection of 200 mg/kg, and extremely high doses (15 g/kg orally or 10 g/kg intravenously) were non-lethal to monkeys.
Human application:
- Clinical studies have shown that oral, intravenous, drip and mucosal (nasal, sublingual, ocular) administration did not cause adverse reactions and was non-irritating to the skin, eyes and muscles.
In summary, HP-β-CD has excellent water solubility and biocompatibility, and exhibits high efficiency and safety in drug delivery systems, and is suitable for a variety of administration routes.
Product testing
Depending on the degree of substitution, the physical and chemical properties of HP-β-CD may vary slightly. The United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) have clear requirements for the molar substitution of HP-β-CD at the pharmaceutical excipient level, which is 0.4~1.5, that is, DS is 2.8~10.5. The Chinese Pharmacopoeia (ChP) does not stipulate the molar substitution, but stipulates the hydroxypropoxy (-OCH2CHOHCH3) content. The hydroxypropoxy content of pharmaceutical excipient-grade hydroxypropyl cyclodextrin, calculated as anhydrous, should be 19.6%~26.3%. As an approved pharmaceutical excipient, HP-β-CD has been used in multiple small molecule pharmaceutical formulations on the market, and can play a role in increasing the solubility and stability of drugs. At present, the role of HP-β-CD in large molecule biological preparations has gradually attracted attention.
The osmotic pressure and viscosity of HP-β-CD are also suitable for injectable drug formulations, and it remains hypotonic over a wide concentration range. The concentration can reach 200mM, which supports the recommended limit for subcutaneous injection (osmotic pressure 600 mOsm/kg, viscosity 20mPas)
Osmotic pressure and viscosity change graph of KLEPTOSE®HP and KLEPTOSE®HPB
Effect
1. It can improve the stability and long-term effect of nutrient molecules
2. It has good water solubility, so after complexing with hydroxypropyl-β-cyclodextrin, the water solubility will be greatly enhanced
3. Reduce the stimulation of organic molecules in cosmetics to skin and mucous membranes, and enhance the stability of active ingredients
4. It is an ideal injection solubilizer and pharmaceutical excipient
5. It can improve the water solubility of poorly soluble drugs, increase the stability of the drug, improve the bioavailability of the drug, increase the efficacy of the drug or reduce the dosage, adjust or control the release speed of the drug, and reduce the toxic and side effects of the drug.
Application direction
1. In the field of food and spices, it is used to improve the stability and long-term effect of nutritional molecules, to mask or correct the bad smell and taste of food nutritional molecules, and to improve the production process and product quality.
2. Used as stabilizer, emulsifier, deodorant, etc. in cosmetic raw materials, it can reduce the stimulation of organic molecules in cosmetics to skin and mucous membrane tissues, enhance the stability of active ingredients, and prevent the volatilization and oxidation of nutrients. It has a certain relative hygroscopicity.
3. In the pharmaceutical industry, it is an ideal injection solubilizer and pharmaceutical excipient due to its relatively low surface activity and hemolytic activity and no irritation to muscles.
Company Introduction And Certificates Obtained
YTBIO mainly supplies Hydroxypropyl Beta Cyclodextrin etc. The company was established in 2014 and has many years of R&D and production experience. We are committed to the research and development, production and sales of raw materials for the 21st century health industry. The certificates obtained so far include ISO9001, ISO22000, HALAL, KOSHER, HACCP, FDA,etc. We always maintain the highest requirements for product quality.
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