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Adv Drug Deliv Rev. 2001 May 16;48(1):67-90.

Characterization of the solid state: quantitative issues.

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  • 1Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.


Quantitative analysis of solid state composition is often used to ensure the safety and efficacy of drug substances or to establish and validate the control of the pharmaceutical production process. There are a number of common techniques that can be applied to quantify the phase composition and numerous different methods for each technique. Each quantitative option presents its own issues in ensuring accuracy and precision of the solid state method. The following article describes many of the common techniques that are used for quantitative phase analysis and many of the considerations that are necessary for the development of such methods.

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