BRIEFING

 Inositol. FCC 15. On the basis of comments and data received, the following revisions are proposed:

1. Add the chemical name, cis-1,2,3,5-trans-4,6-Cyclohexanehexol, to the Chemical Information section.

2. Update the Description to include the manufacturing information.

3. Update Identification A with an infrared spectroscopy test.

4. Update Identification B with an HPLC retention time agreement test.

5. Update the Assay to an HPLC-RI test.

6. Add Arsenic, Cadmium, and Mercury to the Inorganic Impurities and update the method and the Acceptance criteria for Lead.

7. Add the Organic Impurities to the Impurities.

 Stakeholders are specifically invited to provide comments and data regarding the Acceptance criteria in the test for Inorganic Impurities.

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

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

 (FI: J. Kong)

 Case ID—SUB-2978