Hydroxypropyl Betadex Analysis Service

Hydroxypropyl Betadex Analysis Service

Cutting-edge Hydroxypropyl Betadex Analysis Solutions to Aid Your Research

CD BioGlyco is a cutting-edge company for carbohydrate-related pharmaceutical and bioanalytical services, providing reliable Pharmaceutical Analysis Service, Biological Evaluation Service, and Pharmaceutical Excipient Analysis Service. Pharmaceutical excipients are an important part of pharmaceutical preparations and determine their performance, safety, effectiveness, and stability. Therefore, the measurement of functional-related indicators is of great significance to ensure the quality of preparations.

Hydroxypropyl betadex, a common pharmaceutical excipient, is a type of hydroxy alkylated hydrophilic derivative formed by the condensation of beta-cyclodextrin and 1,2-propylene oxide. We provide one-stop analytical services of hydroxypropyl betadex to clients around the world through various technologies to characterize its physical and chemical properties.

Our services cover all aspects of hydroxypropyl betadex pharmaceutical excipients analysis, including but not limited to:

The comprehensive analysis for hydroxypropyl betadex. (CD BioGlyco)

  • Physical properties
    We provide information on the physical properties of the pharmaceutical excipients, such as color, shape, solubility in water and organic solvents, solution clarity and color, etc.
  • Content determination
    We use gas chromatography to help clients determine the hydroxypropyl group contained in hydroxypropyl beta cyclodextrin pharmaceutical excipients. Calculate the content of hydroxypropyl beta cyclodextrin by comparing the peak areas of the test solution and the reference solution.
  • pH determination
    Determine the pH value of hydroxypropyl beta cyclodextrin pharmaceutical excipients to indicate the hydrogen ion activity in the solution. We use an acidometer to measure the pH of a solution.
  • Chloride determination
    Observe and compare the control solution made from the test solution and the standard sodium chloride solution to determine whether the test solution contains chloride.
  • Conductivity determination
    Conductivity is a physical quantity that characterizes the ability of an object to conduct electricity and reflects the total amount of electrolytes in the water. We use a conductivity meter to help clients measure the conductivity of hydroxypropyl beta cyclodextrin solution at 20°C.
  • Determination of related substances
    • Moisture: Use the moisture determination method to determine the moisture content in the sample.
    • Ignition residue: Use a crucible to determine the residue content in the sample.
    • Heavy metals: Detect the content of metal impurities in the test object that react with thioacetamide or sodium sulfide to develop color under specified experimental conditions.
    • Microbial limit: Determine the total number of aerobic bacteria, mold, and yeast in the sample.
    • Beta cyclodextrin: Compare the sample and the reference solution (cyclodextrin reference substance and 1,2-propanediol reference substance) through high-performance liquid chromatography, and use the external standard method to calculate the content of cyclodextrin and 1,2-propanediol in the sample based on the peak area.
    • Propylene oxide: Determine the sample solution and propylene oxide reference solution using gas chromatography, and calculate the content of propylene oxide in the sample using the external standard method.

Publication

Technology: Combining excipients in monoclonal antibody formulations

Journal: Pharmaceuticals

IF: 4.6

Published: 2024

Results: Hydroxypropyl beta-cyclodextrin is a versatile and chemically stable excipient that exhibits remarkable stability under various stress conditions including heat, light, and oxidative environments. Hydroxypropyl beta-cyclodextrin has the potential to become an alternative to polysorbates, which are widely used in antibody formulations but have been limited by efficiency and safety issues. Here, the authors combined hydroxypropyl beta-cyclodextrin and polysorbate into two monoclonal antibodies. The results showed that protein aggregation was significantly reduced, and the combination of the two excipients served as excipients to improve the stability of the monoclonal antibody in the preparation.

Fig.1 Combined HPβCD and polysorbate in mAb formulation.Fig.1 Combined hydroxypropyl beta-cyclodextrin and polysorbate in monoclonal antibody forzmulation. (Huang, et al., 2024)

Applications

  • Evaluate and optimize information such as the presence, content, and impurities of hydroxypropyl beta-cyclodextrin in various formulations and products to assist production research and development, quality control, and product optimization.
  • Evaluate how hydroxypropyl beta-cyclodextrin inclusion complex affects the bioavailability of drugs in vitro and in vivo to further optimize the bioavailability of drugs.
  • Determine the effect of hydroxypropyl beta-cyclodextrin on the chemical and physical stability of active pharmaceutical ingredients to further improve drug stability.
  • Evaluate the effect of hydroxypropyl beta-cyclodextrin on drug solubility and dissolution rates.

Advantages of Us

  • Our professional analytical services accurately and reliably evaluate the content and purity of hydroxypropyl beta-cyclodextrin in pharmaceuticals to ensure the efficacy and safety of the final product.
  • Accurately determine the content and purity information of hydroxypropyl beta-cyclodextrin to help you continuously optimize your formulation and achieve the required solubility and stability of the active ingredient.
  • Professional and comprehensive analysis capabilities speed up product development cycles.
  • We also offer customized testing methods to meet the needs of specific projects. This flexibility is critical for custom formulations or innovative applications where standard test methods may not be sufficient.

Frequently Asked Questions

  • What are the physical and chemical properties of hydroxypropyl beta-cyclodextrin?
    β-Cyclodextrin is a cyclic oligosaccharide composed of seven glucose units linked by α-1,4-glycosidic bonds. Hydroxypropyl beta-cyclodextrin is a modified beta-cyclodextrin. Hydroxypropyl modification significantly increases the solubility of beta-cyclodextrin in water and other solvents. It is more stable than natural β-cyclodextrin, resists enzymatic degradation, provides better stability under acidic and alkaline conditions, and forms inclusion complexes with a variety of guest molecules. Hydroxypropyl beta-cyclodextrin is widely used in pharmaceuticals to improve drug solubility and bioavailability.
  • What are the common challenges for hydroxypropyl beta-cyclodextrin analysis?
    • It has no characteristic ultraviolet (UV) absorbance or fluorescence.
    • It affects the wavelength and absorbance values of the UV and visible spectra of guest molecules and matrix components.
    • It encapsulates commonly used analytical reagents and surfactant excipients in its internal cavity and interferes with their formation of inclusion complexes.
    • It may interact with components of solvents, eluents, and buffer additives used in common separation techniques.

At CD BioGlyco, our services cover all aspects of carbohydrate-related pharmaceutical excipient analysis. Please feel free to contact us to learn how we can help our clients track the quality and safety of their pharmaceutical products.

Reference

  1. Huang, J.; et al. Investigation on the combined effect of hydroxypropyl beta-cyclodextrin (HPβCD) and polysorbate in monoclonal antibody formulation. Pharmaceuticals. 2024, 17(4): 528.
This service is for Research Use Only, not intended for any clinical use.

Christmas 2024

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CD BioGlyco is a world-class biotechnology company with offices in many countries. Our products and services provide a viable option to what is otherwise available.

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