Assessing the Physicochemical Stability of a Compounded Neonatal Trace Element Solution.

Area of Science:

• Pharmaceutical Sciences
• Neonatal Medicine
• Analytical Chemistry

Background:

• Alberta Health Services (AHS) proposed a new multi-trace element formulation for neonatal care.
• This formulation includes zinc sulfate, copper sulfate, selenious acid, and sodium iodide.
• Compounding and stability assessment are crucial for ensuring neonatal patient safety.

Purpose of the Study:

• To evaluate the physicochemical stability of a new neonatal multi-trace element formulation.
• To assess stability under various storage conditions (room temperature and refrigeration).
• To determine the optimal storage duration for the compounded formulation.

Main Methods:

• Three batches of the trace element solution were prepared using sterile compounding procedures.
• Samples were stored in vials and syringes at room temperature (15-30°C) and refrigerated (2-8°C).
• Physicochemical properties (appearance, pH) and elemental concentrations (Zn, Cu, Se, I) were analyzed over 90 days.

Main Results:

• Zinc, copper, and selenium concentrations remained within acceptable limits for up to 90 days in vials.
• Iodine concentration exceeded limits after 7 days, regardless of storage conditions.
• Samples in syringes at room temperature showed reduced zinc levels within 12 hours.

Conclusions:

• The AHS neonatal multi-trace element formulation demonstrates physicochemical stability in vials for up to 7 days.
• Iodine instability after 7 days necessitates careful consideration for extended storage.
• Further method validation for iodine analysis is recommended.