Technical Specification & Application Guide: 2-Hydroxypropyl-β-Cyclodextrin (HP-β-CD)
Name: 2-Hydroxypropyl-β-Cyclodextrin
Cas: 128446-35-5
Purity: 99%
MOQ: 1KG
Directory Guidance on 2-Hydroxypropyl-β-Cyclodextrin
Chemical Structure
Basic Info
| Melting point | 278 °C (dec.) |
| Boiling point | 400℃ |
| density | 1.05 at 20.3℃ |
| refractive index | 125 ° (C=1, H2O) |
| storage temp. | room temp |
| solubility | H2O: 45 % (w/v) |
| form | solution (clear, colorless) |
| color | White to slightly yellow |
| PH | 5.0-7.0 (20g/L in H2O) |
| biological source | synthetic (organic) |
| Optical Rotation | [α]26/D +139°, c = 1 in H2O |
| Water Solubility | Soluble in water. |
To ensure seamless integration into international pharmaceutical and industrial supply chains, our production lines operate under standard operating procedures designed to fulfill global regulatory mandates.
Pharmaceutical Standards: Fully compliant with current monographs in USP (United States Pharmacopeia), EP (European Pharmacopoeia), and ChP (Chinese Pharmacopoeia).
ISO Quality Management Systems: Manufactured under ISO 9001:2015 quality assurance protocols to guarantee batch-to-batch consistency and process control.
Good Manufacturing Practice Compliance: Facilities follow cGMP principles, enforcing strict hygiene control, environmental monitoring, and traceability from raw materials to final packaging.
Halal & Kosher Documentation: Available upon request for food and cosmetic grade formulations requiring specific cultural or dietary certifications.
REACH Compliance: Fully documented for European Union chemical import standards, complete with comprehensive Safety Data Sheets (SDS) adhering to GHS guidelines.
Quality assurance at Zhishang Chem relies on stringent, multi-tiered testing protocols executed by experienced analytical chemists. Every batch of 2-Hydroxypropyl-β-Cyclodextrin undergoes multi-step verification prior to packaging and release.
[Raw Material Receipt] ──► [In-Process Reaction Control] ──► [Purification & Crystallization]
│
▼
[Certificate of Analysis Issued] ◄── [Final Batch Sampling] ◄── [HPLC / GC / IR Analytical Testing]
High-Performance Liquid Chromatography (HPLC / RID):
Purpose: Quantitative verification of purity and determination of Molar Substitution (MS) distribution.
Criterion: Absence of unreacted $\beta$-cyclodextrin ($\le 1.0\%$) and related impurities.
Gas Chromatography (GC – Headspace Analysis):
Purpose: Residual solvent quantification (e.g., propylene oxide, organic solvents).
Criterion: Propylene oxide levels maintained strictly below 1 ppm via thermal desorption GC-FID.
Endotoxin & Microbial Load Verification:
Purpose: Ensures safety for parental and oral dosage applications.
Criterion: Total aerobic microbial count (TAMC) $\le 100 \text{ CFU/g}$; Bacterial endotoxins $\le 20 \text{ EU/g}$ for parenteral/injection grade.
Heavy Metals & Elemental Impurities Analysis (ICP-MS):
Purpose: Inductively Coupled Plasma Mass Spectrometry evaluation to ensure heavy metal counts (Lead, Arsenic, Cadmium, Mercury) meet strict limits below 10 ppm total.
Product Packaging
┌──────────────┐
───────► │ \ Cavity / │ ◄── Non-Polar Cavity (Holds Active Ingredient)
│ \______/ │
└──────────────┘
1. Pharmaceutical Formulations (Drug Delivery Excipient)
Solubility & Bioavailability Enhancement: Converts poorly soluble Active Pharmaceutical Ingredients (APIs) — Class II and Class IV under BCS — into clear, bioavailable liquid formulations.
Stability Improvement: Protects sensitive drugs against hydrolysis, oxidation, and photolytic degradation.
Toxicity Mitigation: Reduces localized tissue irritation caused by direct contact with hydrophobic drug compounds during oral, nasal, or parenteral delivery.
2. Cosmetic & Skincare Formulations
Controlled Release of Actives: Encapsulates volatile fragrance oils, retinol, essential oils, and vitamins, providing sustained release across extended wear times.
Malodor Neutralization: Traps malodorous volatile compounds, serving as a functional additive in deodorants and skincare products.
3. Food & Agricultural Applications
Flavor & Nutrient Stabilization: Protects light-sensitive pigments, natural antioxidants, and essential nutrients during high-temperature food processing.
Pesticide Solubilization: Enhances the dispersion and systemic efficacy of hydrophobic agricultural chemicals while reducing active usage volumes.
FAQ
A: Unmodified $\beta$-cyclodextrin exhibits limited water solubility (~$1.85\text{ g}/100\text{ mL}$ at 25°C) due to internal hydrogen bonding. The introduction of hydroxypropyl functional groups breaks these bonds, rendering HP-β-CD extremely soluble in water ($> 50\text{ g}/100\text{ mL}$), which allows for significantly higher inclusion complex concentrations in liquid solutions.
A: We supply multiple distinct grades suited to application requirements:
Parenteral / Injection Grade: Rigorously tested for ultra-low endotoxin levels ($\le 20 \text{ EU/g}$) and high chemical purity.
Oral / Pharmaceutical Grade: Compliant with USP/EP standards for tablets, capsules, and oral solutions.
Cosmetic / Technical Grade: Optimized for topical formulations, stabilization of volatile oils, and industrial application.
A: Accelerated and long-term stability testing conducted in accordance with ICH Q1A(R2) guidelines indicates a stable shelf life of 36 months when stored in unopened, sealed containers in a cool, dry, and dark environment.
A: Sample quantities (50g to 1kg) are available upon request for R&D trial evaluations. Commercial shipments are packed in 10kg fiber drums or 25kg double PE-lined sealed drums to ensure moisture isolation during international transit.
Related References
Pubchem-2-Hydroxypropyl-β-Cyclodextrin
Chemicalbook-2-Hydroxypropyl-β-Cyclodextrin
Manufacturer of 2-Hydroxypropyl-β-Cyclodextrin
1. For products ≤50kg, we recommend using express delivery, which is usually called DDU service (discounted, convenient).
2. For products ≤500kg, we generally recommend air freight, which is usually called FOB, CFR or CIF service (fast and efficient).
3. For products >500kg, we generally recommend shipping by sea, which is usually called FOB, CFR or CIF service (economical, safe).
4. For high-value products, please choose air or express to ensure the safety of product transportation.
