Monitoring
hydration state conversion by TG-DTA |
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Authors: | Kate B Poiesz Carol L Grundner Nancy L Redman-Furey |
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Institution: | (1) Procter and Gamble Pharmaceuticals, Inc., Norwich, New York, USA, 191, 13815 |
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Abstract: | Characterization of the solid-state form (hydrate
or polymorph) of a pharmaceutical active is a key scientific and regulatory
requirement during development of and prior to seeking approval for marketing
of the drug product. A variety of analytical methods are available to perform
this task. By nature of the fundamental information it provides, TG-DTA offers
advantages over other methods in regards to monitoring and quantitation of
hydration state changes. In a single experiment with only a few milligrams
of sample, TG-DTA perceives minor changes in phase, quantitates total water
content and percent conversion, and illustrates hydrate type. All of this
is accomplished without the necessity of generating time-consuming standard
curves representing the differing ratios of hydrated to anhydrous forms. This
study describes the use of TG-DTA to monitor and quantitate humidity induced
solid–solid phase conversion of nitrofurantoin and risedronate. Percent
conversion was qualitatively observed by both TG and DTA signals and quantitated
by the TG. |
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Keywords: | DTA hydrate phase conversion polymorph TG TG-DTA thermal analysis |
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