Defining drug purity through chromatographic and related methods: current status and perspectives

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• Chromatographic and electrophoretic techniques are crucial for drug quality control.
• International Council for Harmonisation (ICH) guidelines provide a regulatory framework for pharmaceutical analysis.
• Modern pharmaceutical research and quality control rely heavily on these analytical methods.

Purpose of the Study:

• To review current requirements for evaluating the purity of chemically synthesized new drug substances and products.
• To explore potential future trends in pharmaceutical purity analysis.

Main Methods:

• Review of current scientific literature and regulatory guidelines.
• Analysis of established chromatographic and electrophoretic techniques.
• Discussion of quality control and assurance in pharmaceutical development.

Main Results:

• Chromatographic and electrophoretic methods are essential for assessing drug substance and product quality.
• Current ICH guidelines formalize common practices in pharmaceutical quality control.
• The review highlights the established role of these techniques in ensuring drug purity.

Conclusions:

• Chromatographic and electrophoretic techniques are indispensable in pharmaceutical quality assessment.
• Adherence to ICH guidelines is key for regulatory compliance in drug purity evaluation.
• Future trends may involve advancements in these analytical techniques for enhanced drug analysis.