Stability of ranitidine hydrochloride at dilute concentration in intravenous infusion fluids at room temperature

Galante, Leonard J.; Stewart, James T.; Warren, Flynn W.; Johnson, Susan M.; Duncan, R.N.

doi:10.1093/ajhp/47.7.1580

Cited by 4 publications

(2 citation statements)

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“…[1][2][3] Review of the literature found 8 articles that reported the stability of ranitidine hydrochloride injectable solutions in polyvinyl chloride (PVC) bags, polypropylene (PP) syringes, glass vials, and glass ampoules. [4][5][6][7][8][9][10][11] Six of the studies involved ranitidine hydrochloride injection packaged in PVC bags with concentrations ranging 0.05 to 2 mg/mL in either normal saline (NS), 5% dextrose in water (D5W), 10% dextrose in water, 5% dextrose with 0.45% sodium chloride, or 5% dextrose with lactated Ringer's. [4][5][6][7][8][9] The longest reported stability in PVC bags was for 92 days at 4°C in NS or D5W.…”

Section: Introductionmentioning

confidence: 99%

“…4-11 Six of the studies involved ranitidine hydrochloride injection packaged in PVC bags with concentrations ranging 0.05 to 2 mg/mL in either normal saline (NS), 5% dextrose in water (D5W), 10% dextrose in water, 5% dextrose with 0.45% sodium chloride, or 5% dextrose with lactated Ringer’s. 4-9 The longest reported stability in PVC bags was for 92 days at 4°C in NS or D5W. One study, involved ranitidine hydrochloride stored in PP syringes at 2.5 mg/mL when diluted with sterile water for injection (SWI), found the solution was stable for up to 94 days (72 hours at 22°C then 91 days at 4°C).…”

Section: Introductionmentioning

confidence: 99%

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Physical Compatibility and Chemical Stability of Injectable and Oral Ranitidine Solutions

Fleming

Donnelly

2018

Hosp Pharm

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Objectives: The physical compatibility and chemical stability of ranitidine hydrochloride injectable solutions and oral syrup were studied to define beyond-use dates (BUDs). Methods: Ranitidine hydrochloride injectable solutions of 25 mg/mL packaged in glass vials and 5 mg/mL in polypropylene (PP) syringes were prepared in triplicate. Samples were refrigerated and protected from light (PFL) or stored at 25°C and either exposed to light (ETL) or PFL. Ranitidine hydrochloride oral syrup 15 mg/mL in unit-dose amber PP syringes were prepared in triplicate and then kept at 25°C. Samples were collected at days 0, 7, 14, 28, 56, and 91. Additional samples were collected at 6 months and at 6, 9, and 12 months for the 25 mg/mL solution and oral syrup, respectively. Physical parameters of pH, clarity, and color were obtained at each collection time. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to determine the chemical stability. Results: Formulations had no significant change in pH or clarity. Although some samples yellowed, this was not associated with a decrease in concentration. The 25 mg/mL solution remained above 98.6% for 6 months, whereas the 5 mg/mL solution remained above 93.5% for 91 days under all storage conditions. At 25°C, the oral syrup retained greater than 98.8% for 12 months. Conclusions: The ranitidine hydrochloride injectable solutions were stable for 6 months and 91 days under the 3 storage conditions, respectively, for the 25 mg/mL solution in glass vials and 5 mg/mL solution in PP syringes. The 15 mg/mL oral syrup in unit-dose amber PP syringes was stable for 12 months at 25°C and PFL.

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