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Characterization of the solid state: quantitative issues
G A Stephenson1, R A Forbes, S M Reutzel-Edens
1Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. gas@lilly.com
Accurate quantitative phase analysis is crucial for drug safety and pharmaceutical manufacturing. This article reviews common techniques and essential considerations for developing precise solid-state methods.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Analytical Chemistry
Background:
- Quantitative analysis of solid-state composition is vital for drug safety and pharmaceutical production control.
- Various techniques exist for quantifying phase composition, each with unique challenges.
Purpose of the Study:
- To describe common techniques for quantitative phase analysis.
- To outline considerations for developing accurate and precise solid-state methods.
Main Methods:
- Review of established quantitative phase analysis techniques.
- Discussion of method development considerations for solid-state characterization.
Main Results:
- Identification of multiple common techniques for quantitative phase analysis.
- Highlighting accuracy and precision challenges in solid-state method development.
Conclusions:
- Selecting the appropriate quantitative phase analysis technique is critical.
- Careful consideration of method development factors ensures reliable solid-state composition analysis.
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