METHOD OF TESTING CRYSTALLINITY IN AMORPHOUS PHARMACEUTICAL COMPOSITIONS

Methods of testing pharmaceutical compositions for the presence or absence of active pharmaceutical ingredient (API) crystallinity in an amorphous solid dispersion or solid-state solution using UV/vis spectrometry is provided. Testing may be performed standalone or during manufacturing of a pharmace...

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Bibliographische Detailangaben
Hauptverfasser:	SPANGENBERG, Angela, BERGHAUS, Andreas
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES MEASURING PHYSICS TESTING
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Beschreibung
Zusammenfassung:	Methods of testing pharmaceutical compositions for the presence or absence of active pharmaceutical ingredient (API) crystallinity in an amorphous solid dispersion or solid-state solution using UV/vis spectrometry is provided. Testing may be performed standalone or during manufacturing of a pharmaceutical composition. A predictive model provides for quantitative analysis of the amount of crystalline API based on UV/vis data of corresponding reference samples. Also provided is an apparatus for manufacturing a pharmaceutical composition.