| 专利名称 | For the preparation of a stable manufacturing process can be used in infusion bag immediately oxidation-sensitive | ||
| 申请号 | JP2018539952 | 申请日 | |
| 公开(公告)号 | JP2019506407A | 公开(公告)日 | 2017-01-23 |
| 申请(专利权)人 | 发明人 | トゥーシャー ヒンゴラニ; ササンク チャイタニャ クナダーラジュ; トゥーシャー マルカーン; サティーシュ ペジャヴァール | |
| 专利来源 | 国家知识产权局 | 转化方式 | |
| 摘要 |
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. |
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