Application of iChemExplorer in pharmaceutical pH stress testing

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Drug Development

Background:

• pH stress testing is crucial for pharmaceutical stability studies and regulatory compliance.
• Understanding drug degradation products and pathways is essential for drug safety and efficacy.

Purpose of the Study:

• To evaluate the iChemExplorer (ICE) system as an alternative to conventional methods for drug substance and drug product pH stress testing.
• To assess the efficiency and suitability of ICE technology in pharmaceutical quality control.

Main Methods:

• Comparison of iChemExplorer (ICE) with the conventional manual approach for pH stress testing.
• Utilizing real case studies involving drug substances and drug products.
• Employing a non-isothermal ICE protocol to estimate pH degradation kinetics.

Main Results:

• The iChemExplorer (ICE) system was demonstrated to be an efficient and "fit-for-purpose" alternative for pharmaceutical pH stress testing.
• ICE provides a simple and inexpensive technology for conducting these critical tests.
• The ICE software facilitates the estimation of pH degradation kinetics (e.g., Ea) using non-isothermal protocols.

Conclusions:

• iChemExplorer (ICE) is a viable and effective technology for pharmaceutical pH stress testing.
• The adoption of ICE can streamline the process of validating analytical methods and elucidating degradation pathways.
• ICE offers a valuable tool for pharmaceutical companies seeking efficient and cost-effective stress testing solutions.