Aluminum Content of Neonatal Parenteral Nutrition Solutions

Nutr Clin Pract. 2017 Apr;32(2):266-270. doi: 10.1177/0884533616668789. Epub 2016 Sep 28.

Abstract

Introduction: Calcium chloride (CaCl2) has been the only calcium additive available in the United States that has a low aluminum (Al) content. Calcium gluconate in glass vials (CaGluc-Gl) has a high Al content while calcium gluconate in plastic vials (CaGluc-Pl) has a low Al content. The purpose of this study was to measure Al concentrations in neonatal parenteral nutrition (PN) solutions prepared using various calcium additives.

Methods: Samples of solutions compounded with CaCl2 or CaGluc-Gl and sodium phosphate (NaPhos) as well as CaGluc-Pl and sodium glycerophosphate (NaGP) with and without cysteine were analyzed for Al content. Samples of the cysteine and calcium gluconate additives were also sent for analysis.

Results: Solutions containing CaCl2 and CaGlu-Pl had mean Al concentrations of 1.2-2.3 mcg/dL, while those with CaGlu-Gl had mean concentrations of 14.6-15.1 mcg/dL. Solutions made with NaGP were low in Al content. The measured Al content of 2 lots of the cysteine additive were 168 ± 23 mcg/L and 126 ± 5 mcg/L. The Al concentration equalled 2730 ± 20 mcg/L for the CaGlu-Gl additive and 310 ± 80 mcg/L for the CaGlu-Pl additive.

Conclusion: The study indicates that solutions containing CaCl2 or CaGluc-Pl and NaPhos or NaGP are low in Al content. Using these options for calcium and phosphate additives can limit aluminum intake from neonatal PN to levels within the Food and Drug Administration guideline of ≤5 mcg/kg/d.

Keywords: calcium chloride; calcium gluconate; cysteine; plastic vials; sodium glycerophosphate.

MeSH terms

  • Aluminum / analysis*
  • Calcium Chloride / chemistry
  • Calcium Gluconate / chemistry
  • Cysteine / chemistry
  • Glycerophosphates / chemistry
  • Parenteral Nutrition Solutions / administration & dosage
  • Parenteral Nutrition Solutions / chemistry*
  • Parenteral Nutrition Solutions / standards
  • Phosphates / chemistry
  • United States
  • United States Food and Drug Administration

Substances

  • Glycerophosphates
  • Parenteral Nutrition Solutions
  • Phosphates
  • alpha-glycerophosphoric acid
  • Aluminum
  • Cysteine
  • Calcium Chloride
  • sodium phosphate
  • Calcium Gluconate