Stability and sterility of meglumine gadoterate injection repackaged in plastic syringes.
The analytical and microbiological stability of meglumine gadoterate (Dotarem) repackaged in polypropylene syringe for 3 months at either +4 degrees C or room temperature was studied. For analytical study: six polypropylene syringes (20 ml) were filled with 15 ml of meglumine gadoterate. Three syringes were stored at 4+/-2 degrees C and three at 25+/-2 degrees C, all syringes were kept upright and protected from daylight. Samples were taken on days 0, 6, 14, 30, 45, 60, 75 and 90. Meglumine gadoterate and its degradation product (free Gd3+) concentrations were obtained using a specific HPLC 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 degrees C and protected from daylight. At each day of analysis (0, 15, 35, 45, 60, 75 and 90), four syringes were tested as described in European Pharmacopoeia. After 90 days the concentration of gadoterate remained unchanged and no free Gd3+ were detected. The injectable solution of this gadolinium contrast agent was sterile according to European Pharmacopoeia guidelines. The meglumine gadoterate repackaged in polypropylene syringe was stable for 3 months at all the temperatures studied.
Micard
S
S
Service de Pharmacie et Laboratoire de Toxico-Pharmacologie, Hôpital Robert Debré, 48 Boulevard Sérurier 75019, Paris, France.
Rieutord
A
A
Prognon
P
P
Hassan
M
M
Brion
F
F
D003287:Contrast Media / Q000737:chemistry*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007267:Injections; D008536:Meglumine / Q000737:chemistry*; D009942:Organometallic Compounds / Q000737:chemistry*; D013242:Sterilization; D013594:Syringes
D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine