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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.
Scope of application:
Pharmaceutical hydroxypropyl betacyclodextrin can be used for oral drugs, injections, mucosal drug delivery system (including nasal mucosa, rectum, cornea, etc.), transdermal absorption drug delivery system, lipophilic targeted drug carriers, but also can be used as a protective agent and stabilizer of protein.
Product grade:
Injection grade;Oral grade
Injection Grade Hydroxypropyl Betacyclodextrin 】Basic Information:
Product Name: Hydroxypropyl Betacyclodextrin (Injection Grade)
Appearance: 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 | ||
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 | |
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
Manufacturing
