Investigation of the chemical stability of (d-Phe6, Gln8) GnRH (1–9)-ethylamide (Folligen) by high-performance liquid chromatography

1991 ◽  
Vol 547 ◽  
pp. 121-129 ◽  
Author(s):  
B. Szöke ◽  
Gy. Kéri ◽  
M. Idei ◽  
A. Horváth ◽  
Gy. Bökönyi ◽  
...  
2020 ◽  
Vol 77 (8) ◽  
pp. 649-657
Author(s):  
Anna Bustin ◽  
E Zachary Ramsey ◽  
Brian D Hanna ◽  
Gagan Kaushal

Abstract Purpose To evaluate the physical and chemical compatibilities of treprostinil sodium and dopamine hydrochloride. Methods Treprostinil sodium (4,000, 76,000, and 500,000 ng/mL) were mixed with dopamine hydrochloride (0.6, 3.2, 6, and 40 mg/mL). Samples were obtained at hours 0, 1, 2, and 4 for physical compatibility and chemical stability testing. Physical compatibility was assessed by visual examination and measurements of turbidity and pH. Drug concentrations were assessed using stability-indicating liquid chromatography mass spectrophotometry (LCMS) for treprostinil sodium and stability-indicating high-performance liquid chromatography (HPLC) for dopamine hydrochloride. Results Treprostinil sodium 4,000 and 76,000 ng/mL, when mixed with dopamine hydrochloride 0.6, 3.2, 6, and 40 mg/mL, were stable for 4 hours. Treprostinil sodium 500,000 ng/mL was stable when mixed with dopamine hydrochloride 0.6 mg/mL for 4 hours, but when mixed with dopamine hydrochloride 3.2, 6, and 40 mg/mL, significant precipitation was seen. Conclusion Treprostinil sodium 4,000 and 76,000 ng/mL were stable for 4 hours during simulated Y-site coadministration with dopamine hydrochloride 0.6, 3.2, 6, and 40 mg/mL. Treprostinil sodium 500,000 ng/mL is stable when mixed with dopamine hydrochloride 0.6 mg/mL.


2004 ◽  
Vol 9 (4) ◽  
pp. 254-258
Author(s):  
Wan-Man Ellaria Lee ◽  
Ralph A. Lugo ◽  
William J. Rusho ◽  
Mark MacKay ◽  
John Sweeley

The objective of this study was to determine the chemical stability of extemporaneously prepared lorazepam suspension (1 mg/mL) stored at two temperatures (4°C and 22°C) for 3 months. Lorazepam tablets marketed by two manufacturers (Mylan Pharmaceuticals and Watson Laboratories) were used to extemporaneously formulate two independently prepared suspensions. Each suspension was prepared using sterile water, Ora-Plus® and Ora-Sweet® to achieve a final concentration of 1 mg/mL. The two brands of tablets required different volumes of vehicles to prepare a pharmaceutically optimal suspension. The suspensions were stored in amber glass bottles at 4°C and 22°C for 91 days. Samples were analyzed by high performance liquid chromatography at baseline and on days 2, 3, 7, 14, 21, 28, 42, 63, and 91. The suspensions were considered stable if the mean lorazepam concentration remained greater than 90% of the initial concentration. The chemical stabilities of these two extemporaneously prepared lorazepam suspensions were comparable throughout the study. Both lorazepam suspensions were stable for 63 days when stored at 4°C or 22°C, and both were stable for 91 days when refrigerated at 4°C. When stored at room temperature, the suspension prepared from the Watson tablet retained 88.9 ± 1.4% of the initial concentration on day 91 and was therefore considered unstable, while the suspension prepared from the Mylan tablet was stable for the entire 91-day study.


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