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filingDate 2019-01-16-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2019-05-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber JP-2019081767-A
titleOfInvention Process for producing a stable ready-to-use infusion bag for oxidation sensitive formulations
abstract PROBLEM TO BE SOLVED: To provide a process for minimizing the formation of the most decomposition products during moist heat sterilization of a drug solution of an active pharmaceutical ingredient susceptible to oxidation. The pharmaceutical active ingredient susceptible to oxidation is mixed with an excipient and deoxygenated water to prepare a non-sterile drug solution. The non-sterile drug solution is filled into a moist heat sterilizable soft infusion bag. The soft infusion bag containing the non-sterile drug solution is subjected to final moist heat sterilization at a preset air overpressure of about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The process in which the highest degradation products in parenteral drug products are less than 0.5% by weight of the labeled amount of the active pharmaceutical ingredient susceptible to oxidation in parenteral drug products. 【Selection chart】 None
priorityDate 2013-04-08-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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