• Ann Fr Anesth Reanim · May 2014

    [Physicochemical stability study of injectable solutions of cisatracurium besilate in clinical conditions.]

    • J Pignard, D Bourdeaux, S Kauffmann, J M Constantin, and V Sautou.
    • Pôle pharmacie, CHU G.-Montpied, rue Montalembert, 63003 Clermont-Ferrand, France.
    • Ann Fr Anesth Reanim. 2014 May 1;33(5):304-9.

    ObjectivesTo assess the stability of cisatracurium besilate solution stored at 5°C and 25°C.Materials And MethodsCisatracurium 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.ResultsCisatracurium 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.ConclusionCisatracurium 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.Copyright © 2014 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

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