[Screening for the new formulation of 25% ascorbic acid injection and studies on its stability]

Area of Science:

• Pharmaceutical Sciences
• Formulation Development
• Stability Testing

Context:

• Ascorbic acid (AA) is a vital nutrient and antioxidant, but its injectable formulations are prone to degradation.
• Optimizing injectable AA formulations is crucial for maintaining efficacy and ensuring patient safety.
• Orthogonal design and accelerated stability testing are key methodologies in pharmaceutical development.

Purpose:

• To screen and select optimum new formulations for 25% ascorbic acid injection.
• To estimate the stability of these new formulations under accelerated conditions.
• To study the kinetics of discoloration and concentration variation during anaerobic degradation.

Summary:

• Two optimal 25% ascorbic acid injection formulations (RI and RII) were identified using orthogonal design.
• Accelerated stability testing predicted discoloration shelf-lives of approximately 39 months (RI) and 36 months (RII).
• Content shelf-lives were predicted to be around 40 months (RI) and 38 months (RII), with degradation following pseudo-zero order kinetics.

Impact:

• Provides valuable data for the development of stable injectable ascorbic acid formulations.
• Establishes predictive models for discoloration and concentration changes, aiding in shelf-life determination.
• Demonstrates the utility of accelerated stability testing for forecasting the long-term stability of pharmaceutical products.