Characterization of the solid state: quantitative issues

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 num...

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Bibliographic Details
Published in:Advanced drug delivery reviews 2001-05, Vol.48 (1), p.67-90
Main Authors: Stephenson, Gregory A., Forbes, Robert A., Reutzel-Edens, Susan M.
Format: Article
Language:English
Subjects:
Chemistry, Pharmaceutical
Crystallinity
Crystallography
Near IR
NMR
Pharmaceutical Preparations - analysis
Pharmaceutical Preparations - chemistry
Raman
Solid state
Spectrophotometry
Spectroscopy
X-ray powder diffraction
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Summary: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.
ISSN:0169-409X
1872-8294
DOI:10.1016/S0169-409X(01)00099-0