USP Statement
<729> Globule Size Distribution in Lipid Injection Emulsions
March 29, 2007

USP's Parenteral Products Industrial (PPI) Expert Committee recently approved General Chapter <729> Globule Size Distribution in Lipid Injection Emulsions, with a PFAT5 limit of not greater than 0.05% (see Pharmacopeial Forum 31(5), September–October 2005, page 1448). The standard will appear in the Second Supplement to USP 30–NF 25, with an official date of December 1, 2007. USP has also formed an Advisory Panel to further evaluate the clinical relevance of the lipid droplet size distribution in parenteral emulsions, with particular focus on the "high–end tail" of the droplet size distribution. It is planned that the candidate members of the Advisory Panel will meet in April 2007, as feasible. According to the Rules and Procedures of the Council of Experts, the Advisory Panel is advisory to the PPI Expert Committee. Deliberations of the Advisory Panel are expected to aid the PPI Expert Committee as it continues its discussions of standards for Lipid Injectable Emulsions.

The Advisory Panelists are:

Mary Joan Hampson-Carlin, B.S., M.B.A., Chair
Richard Deckelbaum, M.D.
Bill Heird, M.D.
David B. Lewis, Ph.D.
Dr. Edward Reverdy, Ph.D.
Nancy C. Snow, D.O.
John van den Anker, M.D., Ph.D.