Pharmacopeial compliance of fish oil-containing parenteral lipid emulsion mixtures: Globule size distribution (GSD) and fatty acid analyses

Int J Pharm. 2009 Sep 8;379(1):125-30. doi: 10.1016/j.ijpharm.2009.06.021. Epub 2009 Jun 25.

Abstract

Recently, the United States Pharmacopeia (USP) has established Chapter 729 with GSD limits for all lipid emulsions where the mean droplet size (MDS) must be <500 nm and the percent of fat larger than 5 microm (PFAT(5)) must be <0.05%, irrespective of the final lipid concentration. As well, the European Pharmacopeia (EP) Monograph no. 1352 specifies n3-fatty acid (FA) limits (EPA+DHA> or =45%; total n3 or T-n3> or =60%) for fish oil. We assessed compliance with USP physical and EP chemical limits of two fish oil-containing lipid emulsion mixtures. All lipid emulsions passed USP 729 limits. No samples tested had an MDS >302 nm or a PFAT(5) value >0.011%. Only one product met EP limits while the other failed. All emulsions tested were extremely fine dispersions and easily met USP 729 GSD limits. The n3-FAs profiles were lower in one, despite being labeled to contain 50% more fish oil than the other product. This latter finding suggests the n3-FA content of the fish oil source and/or the applied manufacturing processes in these products is different.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Europe
  • Fat Emulsions, Intravenous / chemistry
  • Fat Emulsions, Intravenous / standards*
  • Fatty Acids, Omega-3 / chemistry
  • Fatty Acids, Omega-3 / standards*
  • Fish Oils / chemistry
  • Fish Oils / standards*
  • Guideline Adherence
  • Pharmacopoeias as Topic
  • United States

Substances

  • Fat Emulsions, Intravenous
  • Fatty Acids, Omega-3
  • Fish Oils