BRIEFING

 Appendix VII: Fats and Related Substances. First Supplement to FCC 14. On the basis of comments and data received, the following revisions are proposed:

1. Change the method name Differentiation of Plant Oils Using Chemical Markers to Sterol Profile (Method II).

2. Move Sterol Profile (Method II) to follow the existing Sterol Profile, which is renamed Sterol Profile (Method I). Add a Note to clarify that Method I should be used unless otherwise indicated in the monograph.

3. Incorporate the following changes into the newly named Sterol Profile (Method II):

   • Update the System suitability solution preparation.

   • Update the standards information in Table 6 and renumber as Table 16.

   • Update the Sample solution preparation.

   • Update the Chromatographic system conditions and Suitability requirements.

   • Update the analytes and retention times in Table 7 and renumber as Table 17.

   • Update the typical ranges in Table 8 and renumber as Table 18.

   • Remove the subsection GC-MS for Confirmation of Sesamin.

4. Add a table title to one of the existing tables in Waxes.

 Additionally, minor editorial changes have been made to update the Appendix to current USP style.

 This proposal is targeted for publication in the First Supplement to FCC 15.

 (FI: J. Kong)

 Case ID—SUB-726