J Pignard1, D Bourdeaux2, S Kauffmann3, J M Constantin4, V Sautou5. 1. Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France. 2. Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France; Université d'Auvergne, EA 4676C-Biosenss, UFR médecine-pharmacie, place Henri-Dunant, 63001 Clermont-Ferrand, France. 3. Pôle bloc chirurgical, chirurgie et anesthésie-réanimation, CHU G.-Montpied, rue Montalembert, 63000 Clermont-Ferrand, France. 4. Pôle ressources interventionnelles - anesthésie-réanimation, CHU Estaing, rue Lucie-Aubrac, 63100 Clermont-Ferrand, France. 5. Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France; Université d'Auvergne, EA 4676C-Biosenss, UFR médecine-pharmacie, place Henri-Dunant, 63001 Clermont-Ferrand, France. Electronic address: vsautou@chu-clermontferrand.fr.
Abstract
OBJECTIVES: To assess the stability of cisatracurium besilate solution stored at 5°C and 25°C. MATERIALS AND METHODS: Cisatracurium solutions at 2, 5 and 0.1mg/mL in 0.9 % sodium chloride or 5 % glucose were exposed to 5°C and 25°C under 60 % relative humidity for seven days. The physicochemical stability was assessed at 24, 48hours and seven days with dosage of the active substance, detection of degradation products and a possible racemization, measuring pH, osmolality and turbidity, assessment of coloration, visible particles and invisible particles count. RESULTS: Cisatracurium besilate present good stability for 24hours at 5°C and 25°C for concentrations between 0.1 and 5mg/mL. Beyond 24hours, the solutions at 2 and 5mg/mL remained stable for seven days at 5°C. At 25°C, potentially toxic degradation products appear in solutions of 0.1mg/mL between 24 and 48hours. No racemization was detected, the drug remains in its active form cis. CONCLUSION: Cisatracurium solutions at 2 and 5mg/mL may be stored at 5°C or 25°C for seven days. It's advisable to keep the solutions in a dilution of 0.1mg/mL in 0.9 % sodium chloride or 5 % glucose in the refrigerator. No diluted solution should be stored at room temperature beyond 24hours.
OBJECTIVES: To assess the stability of cisatracurium besilate solution stored at 5°C and 25°C. MATERIALS AND METHODS:Cisatracurium solutions at 2, 5 and 0.1mg/mL in 0.9 % sodium chloride or 5 % glucose were exposed to 5°C and 25°C under 60 % relative humidity for seven days. The physicochemical stability was assessed at 24, 48hours and seven days with dosage of the active substance, detection of degradation products and a possible racemization, measuring pH, osmolality and turbidity, assessment of coloration, visible particles and invisible particles count. RESULTS:Cisatracurium besilate present good stability for 24hours at 5°C and 25°C for concentrations between 0.1 and 5mg/mL. Beyond 24hours, the solutions at 2 and 5mg/mL remained stable for seven days at 5°C. At 25°C, potentially toxic degradation products appear in solutions of 0.1mg/mL between 24 and 48hours. No racemization was detected, the drug remains in its active form cis. CONCLUSION:Cisatracurium solutions at 2 and 5mg/mL may be stored at 5°C or 25°C for seven days. It's advisable to keep the solutions in a dilution of 0.1mg/mL in 0.9 % sodium chloride or 5 % glucose in the refrigerator. No diluted solution should be stored at room temperature beyond 24hours.