Optimization of the production process of Citicoline Sodium Injection based on QbD
Objective To optimize the production process of Citicoline Sodium Injection based on quality by design(QbD),and ensure product safety,effectiveness and quality control.Methods Based on the concept of QbD,the quality target product profile(QTPP)and the critical quality attributes(CQA)of Citicoline Sodium Injection were determined,and combined with the risk assessment of the process variables,the liquid dispensing and sterilization process of Citicoline Sodium Injection were studied,and the optimal process conditions were screened and determined.Results By controlling the temperature of water for injection below 40℃,adjusting the pH value between 6.2 and 8.0,using the terminal sterilization process 121℃/12 min,controlling the sterilization heating time less than 15 min,cooling time less than 10 min,the quality of the prepared products met the requirements.Conclusion Using the optimized process parameters,the terminal sterilization of Citicoline Sodium Injection can be realized,the sterility level of the product can be improved,and the clinical drug safety can be improved.
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