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

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 <500nm and the percent of fat larger than 5μm (PFAT5) 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≥45%; total n3 or T-n3≥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 >302nm or a PFAT5 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. [Copyright &y& Elsevier]