BRIEFING

 Sodium Oleate. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. On the basis of comments received and additional supporting data and validation reports, the proposals for this excipient, which appeared in PF 45(5) [Sep.–Oct. 2019] and PF 47(6) [Nov.–Dec. 2021], have been canceled and are being replaced with a new proposal.

 Sodium Oleate is available in two types, Sodium Oleate 60 and Sodium Oleate 95, based on oleic acid content.

1. The Assay is based on determination of sodium content by potentiometric titration method. The sodium value determined by this validated method is highly accurate compared to the flame photometric method that was published in PF 47(6).

2. The dl-α-Tocopherol Content test is based on an RP-HPLC method of analysis performed with the Phenomenex Kinetex brand of column with L1 packing. The typical retention time for α-tocopherol is about 6.7 min. This method quantifies α-tocopherol using an external standard by using UV detection at 293 nm.

 (CE: R. Challa)

 Correspondence Number—C247815