A process is provided for minimizing the formation of the most abundant degradation products during moist heat sterilization of a medicinal active ingredient susceptible to oxidation. A non-sterile drug solution is prepared by mixing an active pharmaceutical ingredient susceptible to oxidation with an excipient and deoxygenated water. The non-sterile drug solution is filled into a soft infusion bag that can be sterilized with heat and humidity. A soft infusion bag containing non-sterile drug solution is sterilized by final moist heat at a preset air overpressure of about 0.2 bar to about 1.2 bar to obtain a parenteral drug product. The most frequent degradation products in parenteral drug products are less than 0.5% by weight of the labeling amount of active pharmaceutical ingredients susceptible to oxidation in parenteral drug products.酸化を受けやすい医薬品有効成分の薬液の湿熱滅菌中の最も多い分解生成物の形成を最小限にするためのプロセスを提供する。酸化を受けやすい医薬品有効成分を、賦形剤および脱酸素水と混合して、非無菌薬液を調製する。非無菌薬液を、湿熱滅菌可能な軟質注入バッグに充填する。非無菌薬液を含む軟質注入バッグを、事前設定した空気過剰圧約０．２バール～約１．２バールで最終湿熱滅菌して、非経口薬物製品を得る。非経口薬物製品中の最も多い分解生成物は、非経口薬物製品中の酸化を受けやすい医薬品有効成分のラベル表示量の０．５重量％未満である。
