Van Matre Edward T, Rice Peter J, Wempe Michael F, Lyda Clark, Kiser Tyree H
University of Missouri School of Medicine, Columbia, MO, USA.
University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.
Hosp Pharm. 2023 Apr;58(2):183-187. doi: 10.1177/00185787221125722. Epub 2022 Sep 28.
Evaluate the stability of isoproterenol hydrochloride injection in 0.9% sodium chloride in polyvinyl chloride bags for up to 90 days. Dilutions of isoproterenol hydrochloride injection to a concentration of 4 μg/mL were performed under aseptic conditions. The bags were stored in amber ultraviolet light blocking bags at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at baseline, each analysis day, and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of isoproterenol hydrochloride was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Isoproterenol hydrochloride diluted to 4 μg/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags diluted to 4 μg/mL had <10% degradation when stored under refrigeration (3°C-5°C) or stored at room temperature (23°C-25°C). Isoproterenol hydrochloride diluted to a concentration of 4 μg/mL with 0.9% sodium chloride for injection in ultraviolet light blocking bags was stable for 90 days at room temperature and under refrigeration.
评估盐酸异丙肾上腺素注射液在聚氯乙烯袋中0.9%氯化钠溶液中长达90天的稳定性。在无菌条件下将盐酸异丙肾上腺素注射液稀释至浓度为4μg/mL。袋子储存在琥珀色避光袋中，置于室温（23°C - 25°C）或冷藏（3°C - 5°C）环境下。在第0、2、14、30、45、60和90天对每种制剂和储存环境的三个样品进行分析。通过目视检查评估物理稳定性。在基线、每个分析日以及最终降解评估时测定pH值。未评估样品的无菌性。使用液相色谱 - 串联质谱法评估盐酸异丙肾上腺素的化学稳定性。如果初始浓度降解<10%，则样品被认为是稳定的。在整个研究过程中，用0.9%氯化钠注射液稀释至4μg/mL的盐酸异丙肾上腺素在物理上是稳定的。未观察到沉淀。在第2、14、30、45、60和90天，当储存在冷藏（3°C - 5°C）或室温（23°C - 25°C）下时，所有稀释至4μg/mL的袋子中盐酸异丙肾上腺素的降解均<10%。用0.9%氯化钠注射液稀释至浓度为4μg/mL并置于避光袋中的盐酸异丙肾上腺素在室温和冷藏条件下90天内是稳定的。
