Stability of Trisodium Citrate 4.0% and 46.7% in Polyvinyl Chloride Syringes

ABSTRACT Objective: To evaluate the stability of solutions of trisodium citrate in saline, prepared under standard sterile pharmaceutical conditions and stored in 5-mL polyvinyl chloride (PVC) syringes. Methods: Two concentrations of trisodium citrate, 4.0% and 46.7%, were tested. Samples were transferred to individual syringes, stored at room temperature (21°C), and kept away from sunlight. The samples were analyzed with a stabilityindicating high-performance liquid chromatography method on days 1, 3, 7, 14, and 28. Results: There was no significant decrease (less than 10%) in the trisodium citrate concentration in either solution, even after 28 days of storage. Conclusion: Solutions of trisodium citrate both 4.0% (extemporaneously prepared) and 46.7% (commercially available), are stable for at least 28 days when stored at room temperature in PVC syringes. RESUME Objectif : Evaluer la stabilite de citrate de sodium, dans des solutions salines entreposees dans des seringues de chlorure de polyvinyle de 5 mL et preparees selon les techniques pharmaceutiques steriles standard. Methodes : Deux preparations du medicament a des concentrations de 4,0 % et 46,7 % ont ete etudiees. Les echantillons, mis dans des seringues individuelles et entreposes a la temperature ambiante (21 °C), a l’abri de la lumiere du soleil, ont ete analyses au jour 1, 3, 7, 14 et 28, au moyen d’une epreuve de stabilite par chromatographie liquide a haute pression. Resultats : L’analyse n’a revele aucune diminution significative (moins de 10 %) de la concentration en citrate de sodium des solutions a 4,0 % et a 46,7 %, meme apres 28 jours d’entreposage. Conclusion : Les preparations extemporanees de citrate de sodium a des concentrations de 4,0 % et de 46,7 % dans des seringues de chlorure de polyvinyle sont stables pendant au moins 28 jours.