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- W2741605858 abstract "<h3>Objective</h3> We aimed to monitor the physicochemical stability of prostaglandin E<sub>1</sub> (PGE<sub>1</sub>) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes. <h3>Methods</h3> We developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE<sub>1</sub>. Method selectivity was performed with a mixture of PGE<sub>1</sub> and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE<sub>1</sub> injection solutions in 10% dextrose were stored in unprotected and shielded-from-light polypropylene syringes in a climatic chamber. Samples were taken immediately after preparation (T<sub>0</sub>) and after 24, 48, 72 and 168 hours for analysis. PGE<sub>1</sub> solutions were considered stable if ≥90.0% of the initial concentration was retained. <h3>Results</h3> The LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE<sub>1</sub> with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of <2.2%and <4.7%, respectively. The quantification and detection limits of the method were 0.086 and 0.026µg/mL, respectively. PGE<sub>1</sub> and its degradation products were resolved chromatographically. PGE<sub>1</sub> injection solutions were≥90.0%stable after 48hours in unprotected from light (UPL) syringes. The solutions remained clear without precipitation, colour or pH modification and subvisible particles within the permitted levels. Prostaglandin A<sub>1</sub> was the sole degradation product observed. <h3>Conclusions</h3> A LC-HRMS method to evaluate PGE<sub>1</sub> stability in a 10% dextrose was developed and validated. PGE<sub>1</sub> 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes." @default.
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- W2741605858 date "2017-08-02" @default.
- W2741605858 modified "2023-09-26" @default.
- W2741605858 title "Stability of prostaglandin E1 solutions stored in polypropylene syringes for continuous intravenous administration to newborns" @default.
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- W2741605858 doi "https://doi.org/10.1136/ejhpharm-2017-001205" @default.
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