Arsenic release from glass containers by action of intravenous nutrition formulation constituents

Int J Pharm. 2006 Jun 6;315(1-2):24-9. doi: 10.1016/j.ijpharm.2006.02.008. Epub 2006 Apr 18.

Abstract

Pharmacopoeias prescribe tests to determine the levels of arsenic in raw materials and glass containers. In this study, glass ampoules for injectables containing individually the main components of intravenous nutrition formulations were submitted to the hydrolytic resistance test by heating at 121 degrees C for 30 min. As(V) and As(III) levels in these solutions after heating were determined by hydride generation atomic absorption spectrometry. The arsenic content of substances used in these formulations was previously determined, as well as the arsenic content of the glass containers. The results showed that raw substances as well as glass containers contain arsenic. Moreover, arsenic is released during the heating (hydrolytic resistance test). However, the amount released and the arsenic species present in solution depend on the solution composition. While As(V) was the predominant specie in glass, solutions containing reducing substances such as glucose and vitamins had As(III) in higher concentration. Therefore, arsenic is released from glass containers during the heating for sterilization, and reacts with formulation constituents depending on their reducing properties.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Arsenic / administration & dosage*
  • Arsenic / chemistry
  • Construction Materials / adverse effects*
  • Drug Contamination
  • Glass / chemistry*
  • Hazardous Substances / administration & dosage*
  • Hot Temperature
  • Parenteral Nutrition / adverse effects*
  • Solutions / adverse effects
  • Sterilization

Substances

  • Hazardous Substances
  • Solutions
  • Arsenic