Stability and sterility of meglumine gadoterate injection repackaged in plastic syringes

The analytical and microbiological stability of meglumine gadoterate (Dotar em(R)) repackaged in polypropylene syringe for 3 months at either +4 degree sC or room temperature was studied. For analytical study: six polypropylene syringes (20 ml) were filled with 15 ml of meglumine gadoterate. Three syr inges were stored at 4 +/- 2 degreesC and three at 25 +/- 2 degreesC, all s yringes were kept upright and protected from daylight. Samples were taken o n days 0, 6, 14, 30, 45, 60, 75 and 90. Meglumine gadoterate and its degrad ation product (free Gd3+) concentrations were obtained using a specific HPL C assay. Osmolality and pH determination were made on days 0, 14, 45 and 90 . For microbiological study: 28 plastic syringes (5 ml) were filled with 2. 5 ml of meglumine gadoterate. Syringes were stored at 25 +/- 2 degreesC and protected from daylight. At each day of analysis (0, 15, 35, 45, 60, 75 an d 90), four syringes were tested as described in European Pharmacopoeia. Af ter 90 days the concentration of gadoterate remained unchanged and no free Gd3+ were detected. The injectable solution of this gadolinium contrast age nt was sterile according to European Pharmacopoeia guidelines. The meglumin e gadoterate repackaged in polypropylene syringe was stable for 3 months at all the temperatures studied. (C) 2001 Elsevier Science B.V. All rights re served.