BRIEFING

 Chloroquine Phosphate Tablets. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, the previous proposal that appeared in PF 46(1) was canceled and is replaced with the following proposal. It is proposed to revise the monograph with the following changes:

1. In the Identification section:

   • Replace 197U in Identification A with the UV spectrum match from the proposed Assay.

   • Delete Identification B due to safety concerns, and rename the old Identification C as Identification B.

2. In the Assay:

   • Update the Sample solution preparation to provide flexibility for the filter used, and remove the counter ions under the System suitability requirements for consistency throughout the entire monograph.

   • Add the use of a diode array detector to support Identification A.

3. Add an equation to the Dissolution test for consistency with current USP style.

4. Add the Organic Impurities procedure based on a validated LC procedure. The procedure was validated using the Luna C18(2) brand of column with L1 packing. The typical retention time for chloroquine is about 25 min.

5. Add storage requirements in the Packaging and Storage section based on approved package inserts.

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

 (SM1: A. Leeks, Jr)

 Case ID—SUB-1473