Product overview
Hydroxypropyl Beta Cyclodextrin is a highly water-soluble cyclodextrin derivative used to improve the apparent solubility, stability, handling and release profile of poorly soluble guest molecules. Available grades support oral, parenteral, cosmetic and industrial formulation work; substitution level, residual solvents, bioburden and compendial requirements must be matched to the intended use.
Function & Usage
- Bind, Lubricate & Support Dosage Forms
Supports dosage-form processing through binding, lubrication, flow, suspension, taste or texture control according to the selected excipient. Typical uses: Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking.
- Emulsify & Solubilize Ingredients
Supports emulsification or solubilization of oil, fragrance or other formulation components according to the selected ingredient. Typical uses: Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking.
- Soothe, Moisturize & Improve Skin Feel
Supports soothing, moisturization, repair or sensorial improvement according to the selected cosmetic ingredient. Typical uses: Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking.
- Build Detergency & Remove Soil
Supports wetting, detergency, grease removal, foam or soil suspension in suitable cleaning formulations. Typical uses: Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking.
- Deliver Cooling & Protect Volatile Aroma
Provides cooling or helps disperse, protect and control the delivery of volatile flavor and fragrance ingredients. Typical uses: Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking.
Specification
CP 2020
| Item | Specifications | COA Result |
|---|---|---|
| Appearance | White or almost white amorphous or crystalline powder. Highly soluble in water or propylene glycol, freely soluble in methanol or ethanol, and almost insoluble in acetone or trichloromethane. | Conforms |
| Identification - Chemical | A purple ring should be visible at the interface of the two liquids. | Conforms |
| Identification - Infrared Spectrometry | Absorption spectrum of this product should be consistent with that of the reference substance. | Conforms |
| pH | 5.0~7.5 | 6.54 |
| Clarity of solution | It should be clarified that it is colorless | Conforms |
| Chloride | ≤ 0.05% | <0.05% |
| Conductivity(20 °C) | ≤ 200 μs/cm | 59.2 μs/cm |
| Propylene Oxide | ≤ 0.0001% | ND |
| Water | ≤ 6.0% | 3.28% |
| Residue on Ignition | ≤ 0.2% | 0.04% |
| Heavy Metal | ≤10ppm | Conforms |
| Related Substance - Betadex | ≤ 0.5% | 0.03% |
| Related Substance - 1,2-Propylene Glycol | ≤ 0.5% | 0.09% |
| Related Substance - Any Other Single Impurity | ≤0.1% | ND |
| Related Substance - Total Impurities excluding betadex and propylene glycol | ≤1.0% | ND |
| Hydroxypropoxy content | 19.6%~26.3% | 24.60% |
| Microbial Limit - The total aerobic microbial count | ≤ 100 cfu/g | Conforms |
| Microbial Limit - Total count of Molds and Yeasts | ≤ 100 cfu/g | Conforms |
| Microbial Limit - Escherichia coli | Absent | ND |
| Microbial Limit - Salmonella | Absent | ND |
| Bacterial endotoxins | ≤ 20 IU/g | Conforms |
EP 11.0
| Item | Specifications | COA Result |
|---|---|---|
| Appearance | White or almost white amorphous or crystalline powder. Freely soluble in water or propylene glycol | Conforms |
| Identification - Infrared Spectrometry | The infrared spectrum of this product shows the same absorption bands as the standard sample. | Conforms |
| Identification - The Clarity of the Solution | Comply with the standard | Conforms |
| Molar Degree of Substitution | 0.40-1.50 | 0.6 |
| Clarity of solution | 5.0 g/10.0ml water solution is clear and colorless | Conforms |
| Conductivity(20 °C) | ≤200 μs/cm | 52 μs/cm |
| Related Substance - Betadex | ≤1.5% | 0.60% |
| Related Substance - 1,2-Propylene Glycol | ≤2.5% | 0.60% |
| Related Substance - Total Impurities excluding betadex and propylene glycol | ≤1.0% | ND |
| Loss on Drying | ≤10.0% | 5.00% |
| Microbial Limit - The total aerobic microbial count | ≤ 1000 cfu/g | < 10 cfu/g |
| Microbial Limit - Total Count of Molds and Yeasts | ≤ 100 cfu/g | < 10 cfu/g |
| Microbial Limit - Escherichia coli | Absent | ND |
| Microbial Limit - Salmonella | Absent | ND |
| Bacterial endotoxins | ≤ 20 IU/g | < 10 |
Product information
- Primary category:
- Pharmaceuticals & Healthcare, Personal Care & Cosmetic, Detergent & Cleaning, Fine Chemicals
- Subcategory:
- Cyclodextrin Excipients & Solubilizers
- CAS No.:
- 128446-35-5 / 94035-02-6 (substitution-distribution identifiers; confirm the grade)
- Form:
- White powder / 50% aqueous solution
- Content / Grade:
- Injection, oral, cosmetic and industrial grades; USP-NF / EP / ChP or enterprise specifications by grade
- Applications:
- Solubilization and bioavailability support, Drug and active-ingredient stabilization, Taste and odor masking, Controlled-release and formulation development, Cosmetic, detergent and industrial encapsulation
- Hazard / Transport:
- Typical supplied grades are not commonly regulated as dangerous goods. Fine dust may irritate the eyes or respiratory tract and can form combustible dust concentrations in air; confirm the current grade-specific SDS and destination-market transport status.
- Storage:
- Keep tightly sealed in a cool, dry and well-ventilated place. Protect from moisture, heat, direct light, contamination and strong odors.