Extended Stability of Magnesium Sulfate Infusions Prepared in Polyolefin Bags

Abstract

Purpose To investigate the stability of extemporaneously compounded 50 g per 600 mL magnesium sulfate parenteral solution diluted in Lactated Ringer's solution. Methods The sterile preparations of magnesium sulfate were compounded in accordance with USP <797> standards. To carry out the stability testing, these products were stored under 3 different temperature conditions of −20°C, 2°C to 6°C, and 22°C to 25°C. Under the stability studies, pH, particulate matter, and the active content were monitored for 30 days. Results Magnesium sulfate infusions are stable for 30 days when stored at −20°C or 2°C to 6 °C and stable for 30 days under all the temperature conditions studied. These data demonstrate that magnesium sulfate infusions have an extended physical and chemical stability after preparation. Conclusions The stability analysis results show that the shelf-life observed was far better than their recommended expiration dates. This will allow the hospitals to give longer dating to magnesium sulfate preparations, provided they are prepared in a sterile environment and are in compliance with USP <797> guidelines.