title: 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 <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.
authors: Nutrition/Infection Laboratory, Department of Medicine, B.I. Deaconess Medical Center and Harvard Medical School, Boston, MA, USA. d.driscoll.ssi@gmail.com
authors: David F
authors: DF
authors: Driscoll
authors: Pei-Ra
authors: PR
authors: Ling
authors: Bruce R
authors: BR
authors: Bistrian
mesh_terms: D005060:Europe; D005217:Fat Emulsions, Intravenous / Q000737:chemistry / Q000592:standards*; D015525:Fatty Acids, Omega-3 / Q000737:chemistry / Q000592:standards*; D005395:Fish Oils / Q000737:chemistry / Q000592:standards*; D019983:Guideline Adherence; D010602:Pharmacopoeias as Topic; D014481:United States
chemical_list: D005217:Fat Emulsions, Intravenous; D015525:Fatty Acids, Omega-3; D005395:Fish Oils