Stability of penicillin V potassium in unit dose oral syringes

The stability of reconstituted penicillin V potassium (PVK) when stored in 6-ml plastic oral syringes at various temperatures and protected from light was studied. One batch of PVK was reconstituted with distilled water according to manufacturer's directions (label claim: 125 mg/ml). Samples of 5 ml were stored in plastic oral syringes at 4 C, 25 C, 41 C, 60 C or 75 C and assayed spectrophotometrically and microbiogically at various times. From an initial concentration of 113% of label claim, PVK stored at 4 C (refrigerated) reached 90% of manufacturer's label claim in 11.5 days (95% confidence level). PVK stored at 25 C (room temperature) was unstable after storage for less than 37 hours. PVK degradation followed a first-order process. No significant difference was found between the spectrophotometric and microbiological assay (p less than 0.05). Manufacturer's stability data for storage of reconstituted PVK in the original bulk container should not be applied to PVK repackaged in plastic oral syringes. The pharmacy department developed guideliness designed to prevent the administration of subpotent PVK.