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Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers

Author(s):  McCluskey Susan V, Sztajnkrycer Matthew D, Jenkins Donald A, Zietlow Scott P, Berns Kathleen S, Park Myung S

Issue:  Sep/Oct 2014 - Volume 18, Number 5
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Page(s):  432-437

Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 1
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 2
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 3
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 4
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 5
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers Page 6

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Abstract:  Tranexamic acid has recently been demonstrated to decrease all-cause mortality and deaths due to hemorrhage in trauma patients. The optimal administration of tranexamic acid is within one hour of injury, but not more than three hours from the time of injury. To aid with timely administration, a premixed solution of 1 gram tranexamic acid and 0.9% sodium chloride was proposed to be stocked as a medication in both the aeromedical transport helicopters and Emergency Department at Mayo Clinic Hospital—Rochester Saint Marys Campus. Since no published stability data exists for tranexamic acid diluted with 0.9% sodium chloride, this study was undertaken to determine the stability of tranexamic acid diluted with 0.9% sodium chloride while being stored in two types of containers. Stability was determined through the use of a stability-indicating high-performance liquid reverse phase chromatography assay, pH, and visual tests. Tranexamic acid solutions of 1 gram in 0.9% sodium chloride 65 mL were studied at predetermined intervals for 90 days in ethylene/propylene copolymer plastic containers, protected from light, and at both controlled room and refrigerated temperatures. Tranexamic acid solutions of 1 gram in 0.9% sodium chloride 50 mL were studied at predetermined intervals for 180 days in clear Type 1 borosilicate glass vials sealed with intact elastomeric, Flourotec-coated stoppers, stored protected from light at controlled room temperature. Solutions stored in the ethylene/propylene copolymer plastic containers at both storage temperatures maintained at least 98% of initial potency throughout the 90-day study period. Solutions stored in glass vials at controlled room temperature maintained at least 92% of initial potency throughout the 180-day study period. Visual and pH tests revealed stable, clear, colorless, and particulate-free solutions throughout the respective study periods.

Related Keywords: Susan V. McCluskey, RPh, BS Pharm, Matthew D. Sztajnkrycer, MD, PhD, Donald A. Jenkins, MD, Scott P. Zietlow, MD, Kathleen S. Berns, MS, RN, Myung S. Park, MD, hemorrhage, bleeding, surgical blood loss, hemostasis, antifibrinolytic, trauma, storage containers, physical stability, chemical stability, drug potency

Related Categories: STABILITIES, COMPATIBILITIES, HEMOSTASIS, BLEEDING, ANTICOAGULATION, STORAGE

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