A method for preparing a rocuronium bromide injection
By optimizing the moist heat sterilization process of rocuronium bromide injection, increasing the heating temperature and decreasing the cooling temperature, and shortening the high-temperature exposure time, the quality and stability issues in the existing technology were resolved, achieving high stability of the injection and compliance with pharmacopoeia requirements.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- JILIN ZHENAO PHARMA CO LTD
- Filing Date
- 2024-06-27
- Publication Date
- 2026-06-02
AI Technical Summary
In the existing technology, the moist heat sterilization method for rocuronium bromide injection will damage the product quality and stability, especially by increasing the content of impurity V, making it difficult to meet the pharmacopoeia requirements.
The moist heat sterilization process was optimized by increasing the initial heating temperature and decreasing the initial cooling temperature to shorten the high-temperature exposure time. The sterilization conditions were set at 121℃/15min. The optimized sterilization process included a heating phase of 75℃-85℃ and a cooling phase of 5℃-15℃, thus reducing the high-temperature exposure time.
The quality stability of rocuronium bromide injection was significantly improved. Multiple batches of samples met the pharmacopoeia requirements in accelerated stability and long-term stability studies, and the formation of impurity V was significantly reduced.
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