Oxytocin is very commonly used in clinical settings and is a nonapeptide hormone that stimulates the contraction of uterine smooth muscles. In this study the stability of extemporaneously compounded oxytocin solutions was investigated in polyolefin bags. The sterile preparations of oxytocin were compounded to the strength of 0.02 U/mL in accordance with United States Pharmacopeia (USP) <797> standards. In order to carry out the stability testing of these parenteral products, the solutions were stored under three different temperature conditions of −20°C (frozen), 2-6°C (refrigerated), and 22-25°C (room temperature). Three solutions from each temperature were withdrawn and were assessed for stability on days 0, 7, 15, 21, and 30 as per the USP guidelines. The assay of oxytocin was examined by an HPLC method at each time point. No precipitation, cloudiness or color change was observed during this study at all temperatures. The assay content by HPLC revealed that oxytocin retains greater than at least 90% of the initial concentrations for 21 days. There was no significant change in pH and absorbance values for 21 days under all the conditions of storage. Oxytocin parenteral solutions in the final concentration of 0.02 U/mL and diluted in normal saline are stable for at least 30 days under frozen and refrigerated conditions for 30 days. At the room temperature, the oxytocin solutions were stable for at least 21 days. The stability analysis results show that the shelf-life of 21 days observed in this study was far better than their recommended expiration dates.
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.
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