Extended Stability of Ascorbic Acid in Pediatric TPN Admixtures: The Role of Storage Temperature and Emulsion Integrity.

Background/Objectives: This study assessed the chemical and physical stability of ascorbic acid in pediatric total parenteral nutrition (TPN) admixtures under conditions reflecting both hospital compounding and home administration. Methods: Two storage protocols were examined: (A) refrigerated storage (15 days, 4 ± 2 °C) followed by addition of ascorbic acid and a 24-h period of storage at room temperature, and (B) vitamin supplementation within 24 h after composing and storage at 21 ± 2 °C. A validated high-performance liquid chromatography (HPLC) method was used to quantify ascorbic acid degradation. Physical stability was evaluated via optical microscopy, dynamic light scattering (DLS), laser diffraction (LD), zeta potential, and pH measurement. Results: Ascorbic acid content remained above 90% of the declared value in both protocols, although gradual degradation was observed with increasing storage time and temperature. Emulsion droplet sizes remained within pharmacopeial limits (<500 nm), and no coalescence or phase separation was detected. Zeta potential values (-20 to -40 mV) confirmed kinetic stability, while pH ranged from 5.8 to 6.2, remaining within acceptable safety margins. Conclusions: Vitamin C in pediatric TPN admixtures is stable under refrigerated conditions for up to 15 days. However, the additional 24 h at room temperature resulted in measurable loss of ascorbic acid content, suggesting a need for improved guidance in home-based parenteral nutrition, particularly regarding transport and handling. The study underscores the importance of strict cold-chain maintenance and highlights the role of emulsion matrix and packaging in protecting labile vitamins. This research provides practical implications for hospital pharmacists and caregivers, supporting better formulation practices and patient safety in pediatric home TPN programs.