Stability of pantoprazole sodium in glass vials, polyvinyl chloride minibags, and polypropylene syringes |
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Authors: | Donnelly Ronald F |
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Affiliation: | , MSc(Chem), BSc(Pharm), is Product Development Pharmacist with the Department of Pharmaceutical Sciences, The Ottawa Hospital (Civic Campus), Ottawa, Ontario. |
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Abstract: | Background:Pantoprazole sodium, a proton-pump inhibitor, is approved for the short-term treatment of several types of ulcer, Zollinger–Ellison syndrome, and gastroesophageal reflux disease.Objective:To determine the physical compatibility and chemical stability of ethylenediaminetetra-acetic acid (EDTA)–free pantoprazole in glass vials, polypropylene syringes, and polyvinylchloride (PVC) minibags, after storage at 2°C to 8°C with protection from light or at 20°C to 25°C with exposure to light.Methods:Solutions of pantoprazole 4 mg/mL reconstituted in 0.9% sodium chloride (normal saline [NS]) were stored in glass vials at 20°C to 25°C. Similar solutions were transferred to polypropylene syringes and stored at 2°C to 8°C. Stock solution was further diluted, in 5% dextrose in water (D5W) or NS, to 0.4 or 0.8 mg/mL, and samples were then packaged in PVC minibags for storage at 2°C to 8°C or at 20°C to 25°C. Samples collected on days 0, 2, 3, 7, 14, 21, and 28 were analyzed in duplicate with a stability-indicating high-performance liquid chromatography assay.Results:Pantoprazole 4 mg/mL was stable (i.e., retained at least 90% of initial concentration) for 3 days when stored in glass vials at 20°C to 25°C or for 28 days when stored in polypropylene syringes at 2°C to 8°C. Pantoprazole 0.4 mg/mL diluted in D5W and stored in PVC minibags was stable for 2 days at 20°C to 25°C or for 14 days at 2°C to 8°C. At 0.8 mg/mL, pantoprazole in D5W was stable for 3 days at 20°C to 25°C or 28 days at 2°C to 8°C. Pantoprazole diluted to either 0.4 or 0.8 mg/mL in NS and stored in PVC minibags was stable for 3 days at 20°C to 25°C or 28 days at 2°C to 8°C.Conclusions:The present study confirmed or extended previously reported expiry dates for pantoprazole sodium packaged in glass vials, polypropylene syringes, and PVC minibags. |
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Keywords: | pantoprazole sodium injection dextrose normal saline stability high-performance liquid chromatography glass vials polypropylene syringes polyvinylchloride bags |
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