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Stability of Nitroglyercin 100 mcg/mL Stored in Polypropylene Syringes

Author(s):  McCluskey Susan V, Vu Nicole, Rueter John

Issue:  Nov/Dec 2013 - Volume 17, Number 6
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Abstract:  Various angiography procedures at Mayo Clinic (Rochester campus) require small bolus doses of injectable nitroglycerin. Commercially acquired containers of injectable nitroglycerin provide excessive amounts of drug for these procedural needs, so syringes were chosen as a container for dispensing of the dose needed. Due to nitroglycerin’s known chemical attributes of volatility and sorption to plastic surfaces, careful consideration of the stability needs to be taken into account when storing in a syringe. Since there is a lack of stability information in the literature, we studied the stability of nitroglycerin in polypropylene syringes over 90 days. Methods used for this study consisted of a validated stability-indicating high-performance liquid chromatographic assay, visual appearance, and pH. Samples were stored protected from light at ambient controlled temperature and consisted of nitroglycerin 110 mcg/mL in 5% dextrose injection 10.1 mL in 12 mL Terumo polypropylene syringes. Samples were tested at intervals up to 90 days. Results from the visual portion of the study showed clear, colorless, and particulate-free solutions throughout the 90-day study period. The pH results started at 4.27 ± 0.13 (day 0) and ranged from 4.19 ± 0.17 to 4.92 ± 0.43 throughout the study period. Potency test results revealed a day 0 concentration of 104.242 ± 0.193 mcg/mL (batch 1) and 122.483 ±0.168 mcg/mL (batch 2). Results trended downward with percentage of day 0 concentration of 92.2% ± 2.4% at day 14 and of 81.4% ± 4.9% at day 90. Chromatographic profiles of the samples exhibited insignificant changes over the study period. The nitroglycerin peak was spectrally pure based on peak-purity analysis, suggesting that sorption to the polypropylene syringe is one possible reason for the concentration decline over time, but nitroglycerin is a volatile compound and loss through vaporization cannot be ruled out. Nitroglycerin 110 mcg/mL in 5% dextrose injection, packaged in Terumo polypropylene syringes with 10.1 mL aliquots, maintained 90% of syringe potency for 24 days when stored protected from light under controlled ambient conditions.

Related Keywords: Susan V. McCluskey, RPh, BS Pharm, Nicole Vu, PhD, John Rueter, MA, RPh, BS Pharm, injectable nitroglycerin, polypropylene syringes, stability, plastic surface sorption


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