Acta poloniae pharmaceutica 2013-01-01

Stability of calcium folinate (Teva) in concentrate after re-use and in dilute infusions in 0.9% NaCl in polyethylene bags.

Agnieszka Karbownik, Edyta Szałek, Hanna Urjasz, Malwina Kadziołka, Edmund Grześkowiak

Index: Acta Pol. Pharm. 70(2) , 301-7, (2013)

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Abstract

The study concerned the stability of calcium folinate in concentrate in glass vials and diluted in polyethylene (PE) bags stored at 15-25 degrees C and 2-8 degrees C for up to 34 days. Original vials of calcium folinate injection (10 mg/mL, Teva) were stored at room and refrigerator temperatures and subjected to re-piercing at 1, 2, 3, 7, 14, 22, 28, 30 and 34 days following the initial piercing. Calcium folinate infusions at nominal concentrations of 0.12 mg/mL were prepared in 0.9% sodium chloride (250 mL) in PE bags. Chemical stability was measured with a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection in normal light. The concentration of calcium folinate at each sampling time in the analyzed solutions remained > 90% of the initial concentration, regardless of the container. No changes in color or turbidity were observed in any of the vials or in the prepared solutions. Calcium folinate, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 30 days at room and refrigerator temperatures when protected from light.