Descripción
1. What is Hydroxypropyl-beta-Cyclodextrin?
Hydroxypropyl-beta-Cyclodextrin (HP-β-CD) is a water-soluble derivative of beta-cyclodextrin, widely used as an inclusion complexing agent to enhance the solubility, stability, and bioavailability of poorly soluble substances. It is odorless, tasteless, and non-toxic, making it ideal for pharmaceutical, cosmetic, food, and chemical applications.
2. Chemical Properties
| Elementos de prueba | ChP 2020 Standard | USP-NF 2024 Standard |
|---|---|---|
| Apariencia | White or almost white amorphous or crystalline powder. Very soluble in water or propylene glycol, soluble in methanol or ethanol, almost insoluble in acetone or chloroform. | White or almost 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 is clear and transparent; remains transparent at room temperature |
| Identificación | Purple ring appears at the interface of two liquids | Infrared absorption spectrum complies with standard (IR) |
| pH | 5.0–7.5 | N/A |
| Contenido en agua | Not more than 6.0% | ≤10.0% |
| Conductividad | Not more than 200μS/cm | ≤200μS/cm |
| Epoxypropane (Propylene Oxide) | Not more than 0.0001% | ≤1ppm |
| 1,2-Propylene Glycol | No más de 0,5% | ≤2.5% |
| Other Single Impurity (excluding Beta-Cyclodextrin and 1,2-Propylene Glycol) | No más de 0,1% | ≤0.25% |
| Total Other Impurities (excluding Beta-Cyclodextrin and 1,2-Propylene Glycol) | No más de 1,0% | ≤1.0% |
| Beta-ciclodextrina | No más de 0,5% | ≤1.5% |
| Residuos en el encendido | No más de 0,2% | N/A |
| Metales pesados | Not more than 10 ppm | N/A |
| Cloruro | Not more than 0.05% | N/A |
| Hydroxypropoxy Group Content | 19.6%–26.3% | N/A |
| Total Aerobic Microbial Count (cfu/g) | Not more than 100cfu/g | ≤1000cfu/g |
| Total Yeasts and Molds (cfu/g) | Not more than 100cfu/g | ≤100cfu/g |
| Escherichia coli | Absent in 10g | Absent |
| Salmonella | Absent in 10g | Absent |
| Bacterial Endotoxins | N/A | ≤10EU/g |
3. Application
Hydroxypropyl-beta-Cyclodextrin is widely used in:
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Pharmaceuticals: To improve the solubility, bioavailability, and stability of active pharmaceutical ingredients (APIs).
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Cosmetics: To stabilize volatile compounds, control odor release, and enhance product texture.
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Food & Beverages: As a carrier for flavors, vitamins, and sensitive ingredients.
Chemical Industry: As an encapsulation agent for agrochemicals, fragrances, and functional materials.
4. Packing
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1kg aluminum foil bag
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10kg fiber drum
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25kg fiber drum
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