Physical and chemical stability of iron sucrose in parenteral nutrition.
BACKGROUND
Current literature supports iron dextran as the only iron preparation compatible with parenteral nutrition (PN). Iron sucrose has been used for iron replacement therapy because of its lower rate of adverse events. The purpose of this study is to determine the physical and chemical stability of iron sucrose in PN.


METHODS
Physical and chemical stability of iron sucrose in nonlipid PN solutions (PN 1 for neonates and PN 2 for patients weighing >20 kg) is tested over time in triplicate. Physical stability is determined by visually inspecting each PN solution for particulate matter and by filtering and analyzing each aliquot quantitatively for crystal precipitates. Chemical stability is confirmed if the iron concentrations by mass spectrometry remain within United States Pharmacopeia (USP) standards.


RESULTS
Visual clarity is maintained in all PN solutions at hours 0 through 4. PN solution 1 remains clear for hours 8 through 24, whereas PN solution 2 shows an increase in particulate matter by 8 hours. All PN solutions 2 are considered visually incompatible by hour 24. Physical stability of iron sucrose for PN solutions 1 and 2 from hours 0 to 4 is within the USP guidelines for crystalline particulate matter. At hour 24, only solution 1 remains within USP guidelines. Chemical stability data indicate that iron concentrations are maintained throughout the 24-hour time period.


CONCLUSIONS
The physical stability of iron sucrose in PN is time and concentration dependent. Concentrations >0.25 mg/dL showed increasing particulate and should not be added to PN. However, iron sucrose is chemically stable in PN solutions.
MacKay
Mark
M
Primary Children's Medical Center, Salt Lake City, UT 84113, USA. pcmmacka@ihc.com
Rusho
William
W
Jackson
Daniel
D
McMillin
Gwendolyn
G
Winther
Brian
B
D011232:Chemical Precipitation; D003460:Crystallization; D004355:Drug Stability; D017408:Guidelines as Topic; D006801:Humans; D007231:Infant, Newborn; D007505:Iron-Dextran Complex / Q000737:chemistry* / Q000627:therapeutic use; D010288:Parenteral Nutrition / Q000379:methods*; D052638:Particulate Matter; D010602:Pharmacopoeias as Topic
D052638:Particulate Matter; D007505:Iron-Dextran Complex