Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

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
View All Articles in Issue

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

Download in electronic PDF format for $75

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: hemorrhage, bleeding, surgical blood loss, hemostasis, antifibrinolytic, trauma, storage containers, physical stability, chemical stability, drug potency

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

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Stability of Tranexamic Acid in 0.9% Sodium Chloride, Stored in Type 1 Glass Vials and Ethylene/Propylene Copolymer Plastic Containers
McCluskey Susan V
, Sztajnkrycer Matthew D, Jenkins Donald A, Zietlow Scott P, Berns Kathleen S, Park Myung S
Sep/Oct 2014
Pg. 432-437

Stability of Alprostadil in 0.9% Sodium Chloride Stored in Polyvinyl Chloride Containers
McCluskey Susan V
, Kirkham Kylian, Munson Jessica M
Mar/Apr 2017
Pg. 150-153

Stability of Aminocaproic Acid Injection Admixtures in 5% Dextrose Injection and 0.9% Sodium Chloride Injection
Zhang Yan-ping
, Trissel Lawrence A
Mar/Apr 1997
Pg. 132-134

Stability of Dexmedetomidine in 0.9% Sodium Chloride in Two Types of Intravenous Infusion Bags
Marquis Kathleen
, Hohlfelder Benjamin, Szumita Paul M
Sep/Oct 2017
Pg. 436-439

Stability of Dexmedetomidine in Polyvinyl Chloride Bags Containing 0.9% Sodium Chloride Intended for Subcutaneous Infusions
Wolfe Amanda
, Zhang Jeremy, Lapenskie Julie, Downar James, Kanji Salmaan
Jul/Aug 2021
Pg. 330-335

Stability of Tranexamic Acid Mouth Rinse
Donnelly Ronald F
Sep/Oct 2018
Pg. 412-416

Physical and Chemical Stability of Urapidil in 0.9% Sodium Chloride in Elastomeric Infusion Pump
Tomasello Cristina
, Leggieri Anna, Rabbia Franco, Veglio Franco, Baietto Lorena, Fulcheri Chiara, De Nicolò Amedeo, De Perri Giovanni, D'Avolio Antonio
Jul/Aug 2016
Pg. 343-346

Physical and Chemical Stability of Trepostinil Sodium Injection Packaged in Plastic Syringe Pump Reservoirs.
Xu Quanyun A
, Trissel Lawrence A, Pham Lien
May/Jun 2004
Pg. 228-230

Tranexamic Acid 100-mg/mL Injection
Allen Loyd V Jr
Sep/Oct 2014
Pg. 417

In-use Stability of Ceftaroline Fosamil in Elastomeric Home Infusion Systems and MINI-BAG Plus Containers
Bhattacharya Sisir
, Parekh Satish, Dedhiya Mahendra
Sep/Oct 2015
Pg. 432-436

Stability of Extemporaneously Compounded Nadolol 10-mg/mL Suspension in Oral Mix in Glass and Plastic Bottles and Plastic Syringes
Walsh Andrea
, Ziegler Blake, Lingertat-Walsh Karen, Law Shirley, Walker Scott E
Mar/Apr 2021
Pg. 163-168

Comparative Stability of Vitamin K1 Oral Liquids Prepared in Sterile Water for Injection and Stored in Amber Glass Bottles and Amber Plastic Syringes
Huffman Jessica
, Brown Stacy, Lewis Paul, Lawson Sarah, Ogle Amanda, Peacock Gina
Jul/Aug 2018
Pg. 340-344

Chemical Stability of Cefuroxime Sodium After Reconstitution in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes for Pediatric Use
Gupta Vishnu D
Jul/Aug 2003
Pg. 310-312

Compatibility and Stability of Potassium Chloride and Magnesium Sulfate in 0.9% Sodium Chloride Injection and 5% Dextrose Injection Solutions
Quay Irene
, Tan Edward
Jul/Aug 2001
Pg. 323-324

Stability of Dalteparin 1,000 Unit/mL in 0.9% Sodium Chloride for Injection in Polypropylene Syringes
Kirkham Kylian
, Munson Jessica M, McCluskey Susan V, Graner Kevin K
Sep/Oct 2017
Pg. 426-429

Stability of Diphenhydramine Hydrochloride, Lorazepam, and Dexamethasone Sodium Phosphate in 0.9% Sodium Chloride Stored in Polypropylene Syringes
Anderson Collin R
, Halford Zachery, MacKay Mark
Jul/Aug 2015
Pg. 344-347

How to Qualify Container Closure Systems for Intended Use, Part 1
Kim Amy A
, Gehrmann Matthew R, McCaw James, McAndrew T Page
Nov/Dec 2019
Pg. 454-461

Basics of Sterile Compounding: Intravenous Admixture Preparation Considerations, Part 10: Packaging and Container-closure Issues
Allen Loyd V Jr
Jul/Aug 2021
Pg. 311-317

Acidifying Agents, Featured Excipient:
Allen Loyd V Jr
Jul/Aug 1999
Pg. 309-310

Chemical Stability of Cefazolin Sodium after Reconstituting in 0.9% Sodium Chloride Injection and Storage in Polypropylene Syringes for Pediatric Use
Gupta Vishnu D
Mar/Apr 2003
Pg. 152-154

Return to Top