Stability of Procainamide Injection in Clear Glass Vials and Polyvinyl Chloride Bags

Abstract

Objectives: The objective of this study was to evaluate the chemical stability of procainamide hydrochloride, 100 mg/mL, when repackaged in clear glass vials or diluted to 3 mg/mL with normal saline and packaged in polyvinyl chloride (PVC) bags when stored at either 23°C and exposed to light (ETL) or 5°C and protected from light (PFL). Methods: Solutions were assayed using a stability-indicating high-performance liquid chromatography method. Samples (5 mL) were collected from triplicate containers on days 0, 7, 14, 21, 28, 56, 91, and 193. Color/clarity and pH changes were also monitored at each time interval. Results: During the study, all samples remained clear and there was only a slight pH change. The color of the solutions stored at 23°C intensified but did not correlate with a significant decrease in concentration, while solutions stored at 5°C remained unchanged. Solutions repackaged in glass vials were stable for 193 days when stored at 23ºC and ETL or 5ºC and PFL. When further diluted to 3 mg/mL with normal saline and packaged in PVC bags, procainamide was also stable for 193 days at either 23ºC and ETL or 5°C and PFL. Conclusions: The stability of procainamide, 100 mg/mL, repackaged in clear glass vials was 193 days when stored at either 23ºC and ETL or 5ºC or PFL. If diluted further to 3 mg/mL with normal saline and packaged in PVC bags, the drug was also stable for 193 days at either 23ºC and ETL or 5°C and PFL.