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filingDate 2017-01-23-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2018-07-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AU-2017215419-A1
titleOfInvention Process of manufacturing a stable, ready to use infusion bag for an oxidation sensitive formulation
abstract A process for minimizing formation of a highest degradation product during moist heat sterilization of a drug solution of an oxidation susceptible active pharmaceutical ingredient (API) is provided, wherein the water is not deoxygenated and a nitrogen blanket is not used during formulation, or the formulation is stored in ambient conditions in the polymer bag and autoclaved. The highest degradation product in the parenteral drug product is less than 0.1% by weight of a labeled amount of the oxidation susceptible API in the parenteral drug product.
priorityDate 2016-02-05-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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