BRIEFING

 Castor Oil. This proposal is based on the version of the monograph official as of March 1, 2019. On the basis of comments and supporting data received and the lab work performed by USP, it is proposed to make the following changes:

1. Revise the Definition to be aligned with the proposed Triglyceride Composition test for Assay.

2. Revise the Acceptance criteria table in Identification A to apply the limit for oleic acid (C18:1) to the sum of oleic acid (C18:1) and cis-11-octadecenoic acid and to remove the limit for cis-11-octadecenoic acid.

3. Revise the Water Determination test and the Water Determination requirement for use in injectable dosage forms in Other Requirements to add Method Ic.

4. Comments were received that indicated the Triglyceride Composition test for the Assay that uses an evaporative light-scattering detector (ELSD) and a percentage of total detected area (TDA) calculation may have ruggedness issues. The Complex Excipients Expert Committee proposed to improve the test and published a compendial notice: Notice of Intent to Revise: Castor Oil. On the basis of comments received and a validated method, update the quantitative analysis from using the percentage of TDA calculation to using calibration curves of an external standard of glyceryl triricinoleate to quantitate the triglyceride components in the Assay.

5. Reformat the Other Requirements section and make a revision to the Bacterial Endotoxins Test requirement, clarifying that it applies to Castor Oil used in injectable dosage forms.

6. Revise the USP Reference Standards section to include USP Glyceryl Triricinoleate RS.

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

 (CE: P. Zhang)

 Case ID—SUB-608