Testing pharmaceuticals and related substances

An active pharmaceutical ingredients (API) or related substance (RS) can be tested for stability by placing the API or RS in an instrument containing a pressure-controllable atmosphere, controlling the pressure of the atmosphere in the instrument for a predetermined time, and evaluating the API or R...

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Bibliographische Detailangaben
Hauptverfasser:	Evans, Jonathan C, Hilliker, Derrick D, Selby, Theodore W
Format:	Patent
Sprache:	eng
Schlagworte:	CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES MEASURING PERFORMING OPERATIONS PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL PHYSICS TESTING THEIR RELEVANT APPARATUS TRANSPORTING
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Beschreibung
Zusammenfassung:	An active pharmaceutical ingredients (API) or related substance (RS) can be tested for stability by placing the API or RS in an instrument containing a pressure-controllable atmosphere, controlling the pressure of the atmosphere in the instrument for a predetermined time, and evaluating the API or RS for stability. Testing can be carried out also at predetermined temperature(s) and/or under the influence of gaseous trigger(s) and so forth. For instance, an API sample can be placed in a bomb test instrument/reactor, oxygen as a gaseous trigger can be introduced to contact the API sample under constant and/or ramped temperature(s) and elevated pressure(s) for predetermined time(s), and the API sample can be evaluated for stability. An insert carousel may hold a sample of API(s) and/or RS(s) and/or aliquot(s) of sample(s) of API(s) and/or RS(s) for insertion into the bomb test instrument/reactor.