Hydroxypropyl-beta-cyclodextrin
Subcategory:
Pharmaceutical Cyclodextrin
Product Performance:
The introduction of hydroxypropyl breaks the intramolecular cyclic hydrogen bonding of betacyclodextrin, which overcomes the main disadvantage of poor water solubility of betacyclodextrin while maintaining the cyclodextrin cavity. Pharmaceutical hydroxypropyl betacyclodextrin is an ideal solubilizer and drug excipient for injection, and its main functions in the pharmaceutical field are as follows:
1. increase the solubility of drugs, and improve the hydrophilicity of insoluble and oil-soluble drugs; 2. adjust or control the hydrophilicity of drugs.
2. adjusting or controlling the release rate of drugs, protecting the effectiveness of drug components, the application of targeted drug delivery field has great prospects; 3. improving the bioavailability of drugs, protecting the efficacy of drug components.
3. Improve the bioavailability of drugs, so that the efficacy of the agent to increase or reduce the dosage of drugs; 4.
4. can reduce the toxic side effects of drugs, mask the bad odor; 5. can improve the physical and chemical properties of drugs
5. It can improve the physical and chemical properties of the drug, enhance the stability of the drug and improve the prescription.
Application:
Pharmaceutical hydroxypropyl betacyclodextrin can be used for oral drugs, injections, mucosal drug delivery systems (including nasal mucosa, rectum, cornea, etc.), transdermal absorption drug delivery systems, lipophilic targeted drug carriers, but also can be used as a protective agent and stabilizer for proteins.
Product Level:
Injection grade;Oral grade
Injection Grade Hydroxypropyl Betacyclodextrin
Basic information:
Product Name: Injection Grade Hydroxypropyl Betacyclodextrin
Appearance and shape: white powder
CAS NO.：128446-35-5(94035-02-6)
Molecular formula:C42H70-nO35(C3H7O)n , n is the degree of substitution
Molecular weight:1134.98+58n
Quality standard: USP-NF2023, EP10.0, enterprise standard
Injection grade hydroxypropyl betacyclodextrin test standard:
Injection grade hydroxypropyl betacyclodextrin test standard | ||
CAS No.: 128446-35-5 | ||
Test Standard | USP-NF2023 | |
Test items | Index | |
Appearance | This product is a white or off-white amorphous or crystalline powder. Soluble in water and propylene glycol. | |
Appraise | Infrared Spectroscopy | The same absorption bands are presented with the standard samples. |
Solution Clarity | comply with regulations | |
Molar substitution | 0.40-1.50 | |
Clarity of the solution | 1.0g/2ml aqueous solution clear and transparent | |
Dry weight loss | ≤10.0％ | |
Conductivity | ≤200μS | |
Propylene oxide | ≤1ppm | |
1.2-Propanediol | ≤2.5％ | |
Other individual impurities | ≤0.25% | |
Other total impurities | ≤1.0％ | |
Betacyclodextrin | ≤1.5% | |
Total aerobic bacteria (cfu/g) | ≤1000cfu/g | |
Total number of molds and yeasts (cfu/g) | ≤100 cfu/g | |
Bacterial endotoxin (EU/g) | ≤10EU/g | |
Oral Grade Hydroxypropyl Betacyclodextrin Basic Information:
Product Name: Oral Grade Hydroxypropyl Beta-Cyclodextrin
Alias: 2-Hydroxypropyl betacyclodextrin; Hydroxypropyl betacyclodextrin; Hydroxypropyl-beta-cyclodextrin; Hydroxypropylcyclodextrin; Hydroxypropyl cyclodextrin
CAS NO.：128446-35-5(94035-02-6)
Molecular formula：C42H70-nO35(C3H7O)n，n is the degree of substitution
Molecular weight：1134.98+58n
Quality standard：USP-NF2023、EP10.0、ChP2020、enterprise standard
Quality standards for oral grade hydroxypropyl betacyclodextrin:
| Oral Grade Hydroxypropyl Betacyclodextrin Basic Information | ||
Test Standard | ChP2020 | USP-NF2023 |
Test items | Index | Index |
Appearance | This product is a white or off-white amorphous or crystalline powder. It is extremely soluble in water or propylene glycol, soluble in methanol or ethanol, and almost insoluble in acetone or trichloromethane. | This product is a white or off-white amorphous or crystalline powder; soluble in water and propylene glycol. |
Molar substitution | N/A | 0.4-1.5 |
Solution Clarity and Color | Should be clear and colorless | 1.0g/2ml aqueous solution clear and transparent |
Appraise | The interface between the two liquids should show a purple ring | The infrared spectrum shows the same absorption bands (IR) as the standard. |
PH (chemistry) | PH5.0-7.5 | N/A |
Moisture content | ≤6.0% | ≤10.0％ |
Conductivity | ≤200μS/cm | ≤200μS/cm |
Propylene oxide | ≤0.0001% | ≤1ppm |
1.2-Propanediol | ≤0.5% | ≤2.5％ |
Other individual impurities | ≤0.1% | ≤0.25％ |
Other total impurities (except betacyclodextrin and 1,2-propanediol) | ≤1.0% | ≤1.0％ |
Betacyclodextrin | ≤0.5% | ≤1.5% |
Scorch residue | ≤0.2% | N/A |
Heavy metal | ≤10% | N/A |
Chloride | ≤0.05% | N/A |
Hydroxypropoxy content | 19.6%～26.3% | N/A |
Total aerobic bacteria (cfu/g) | ≤100cfu/g | ≤1000cfu/g |
Total number of molds and yeasts (cfu/g) | ≤100cfu/g | ≤100cfu/g |
Total number of pathogenic bacteria (cfu/g) | Not detectable | Not detectable |
Bacterial endotoxin | N/A | Depending on the needs of the formulation |
Oral grade hydroxypropyl betacyclodextrin Packaging for storage:
Packing: in accordance with the pharmaceutical packaging
Packing specification: 0.1kg/bag, 1kg/bag, 2kg/bag, 10kg/bag/drum, 20kg/bag/drum
Storage: Shielded from light, airtight storage
Hydroxypropyl - beta - cyclodextrin (HP - β - CD) is a chemically modified form of beta - cyclodextrin (β - CD), which is a cyclic oligosaccharide composed of seven glucose units. This modification imparts unique and valuable properties to the molecule, making it widely used in various fields.
The chemical structure of HP - β - CD is based on the cyclic structure of β - CD. The hydroxypropyl groups are attached to the glucose units of β - CD through ether linkages. The synthesis of HP - β - CD typically involves reacting β - CD with propylene oxide under alkaline conditions. The degree of substitution (DS), which indicates the average number of hydroxypropyl groups per glucose unit, can be controlled during the synthesis process. A higher DS generally results in different physicochemical properties, such as increased solubility in water.
One of the most notable properties of HP - β - CD is its enhanced solubility compared to β - CD. It is highly soluble in water, which makes it suitable for applications where aqueous solutions are required. This solubility is crucial for its use in pharmaceutical formulations, as it allows for the preparation of stable solutions.
HP - β - CD also has excellent complex - forming ability. It can form inclusion complexes with a wide variety of guest molecules. The cyclic structure of HP - β - CD creates a hydrophobic cavity, while the outer surface is hydrophilic due to the hydroxyl and hydroxypropyl groups. Guest molecules with appropriate size and hydrophobicity can enter the cavity, and the resulting complex can have different properties compared to the free guest molecule. For example, in the pharmaceutical industry, HP - β - CD can form complexes with poorly soluble drugs, improving their solubility and bioavailability.
In pharmaceuticals, HP - β - CD has revolutionized the formulation of many drugs. As mentioned before, it can enhance the solubility of hydrophobic drugs. This is important because poor solubility can limit the absorption and effectiveness of a drug in the body. By forming complexes with drugs like itraconazole, HP - β - CD has enabled the development of more effective oral formulations.
It can also be used to improve the stability of drugs. Some drugs are prone to degradation due to environmental factors such as light, heat, or interaction with other components in the formulation. The inclusion complex with HP - β - CD can protect the drug molecule from these degradation processes.
In the food industry, HP - β - CD can be used as a flavor and odor enhancer. It can form complexes with volatile flavor and aroma compounds, protecting them from evaporation and oxidation, and thus prolonging their release and enhancing the sensory experience.
In the cosmetic industry, it is used in products such as creams and lotions. It can form complexes with active ingredients, improving their stability and delivery to the skin. For example, it can be used to enhance the delivery of vitamins or antioxidants to the skin, providing better skin - care benefits.
HP - β - CD is generally considered safe for use in various applications. However, like any chemical compound, its safety is evaluated based on its intended use and exposure levels. In the pharmaceutical industry, extensive toxicological studies are carried out to ensure its safety for human use. Regulatory agencies around the world, such as the FDA in the United States, have established guidelines for its use in different products.
In conclusion, hydroxypropyl - beta - cyclodextrin is a versatile compound with a wide range of applications due to its unique solubility, complex - forming ability, and other beneficial properties. Its importance is likely to continue to grow in the future as more research is carried out to explore its potential in different fields.
keyword:
Hydroxypropyl-beta-cyclodextrin