title: Stability of Glutamate-Aspartate Cardioplegia Additive Solution in Polyolefin IV Bags.
abstract: OBJECTIVE
  Glutamate-aspartate cardioplegia additive solution (GACAS) is used to enhance myocardial preservation and left ventricular function during some cardiac surgeries. This study was designed to evaluate the stability of compounded GACAS stored in sterile polyolefin intravenous (IV) bags. The goal is to extend the default USP beyond-use date (BUD) and reduce unnecessary inventory waste.
  
  
  METHODS
  GACAS was compounded and packaged in sterile polyolefin 250 mL IV bags. The concentration was 232 mM for each amino acid. The samples were stored under refrigeration (2°C-8°C) and analyzed at 0, 1, and 2 months. At each time point, the samples were evaluated by pH measurement and visual inspection for color, clarity, and particulates. The samples were also analyzed by high-performance liquid chromatography (HPLC) for potency and degradation products. Due to the lack of ultraviolet (UV) chromophores of glutamate and aspartate, the samples were derivatized by ortho-phthalaldehyde prior to HPLC analysis.
  
  
  RESULTS
  The time zero samples of GACAS passed the physical, chemical, and microbiological tests. Over 2 months of storage, there was no significant change in pH or visual appearance for any of the stability samples. The HPLC results also indicated that the samples retained 101% to 103% of the label claim strengths for both amino acids.
  
  
  CONCLUSIONS
  The physical and chemical stability of extemporaneously prepared GACAS has been confirmed for up to 2 months in polyolefin IV bags stored under refrigeration. With proper sterile compounding practice and microbiology testing, the BUD of this product can be extended to 2 months.
authors.affiliation: Wegmans School of Pharmacy, St. John Fisher College , Rochester, New York.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Rush
authors.affiliation: Wegmans School of Pharmacy, St. John Fisher College , Rochester, New York.
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Kim
authors.affiliation: Department of Pharmacy, University of Rochester Medical Center , Rochester, New York .
authors.forename: Susan E
authors.initials: SE
authors.lastname: Hughes
authors.affiliation: Department of Pharmacy, University of Rochester Medical Center , Rochester, New York .
authors.forename: Justine M
authors.initials: JM
authors.lastname: Gilbert
authors.affiliation: Department of Pharmacy, University of Rochester Medical Center , Rochester, New York .
authors.forename: Peter P
authors.initials: PP
authors.lastname: Ciancaglini
authors.affiliation: Wegmans School of Pharmacy, St. John Fisher College , Rochester, New York.
authors.forename: Fang
authors.initials: F
authors.lastname: Zhao
keywords: BUD; aspartate; cardioplegia solution; compounding; glutamate; stability