BRIEFING

 Gadopentetate Dimeglumine Injection. This proposal is based on the version of the monograph official as of May 1, 2020. On the basis of comments received, the Small Molecules 4 Expert Committee proposes to revise the Limit of Pentetic Acid test to be consistent with the sponsor's method and acceptance criteria as follows:

1. Revise Diluent from "Buffer, Indicator solution, and water (30:3:167)" to "Buffer, Indicator solution, and water (30:30:140)".

2. Revise the Sample solution from “Transfer volume of Injection equivalent to 938 mg of gadopentetate dimeglumine. Add 20 mL water and 10 mL Diluent. Adjust with 0.1 N sodium hydroxide or glacial acetic acid to a pH of 5.” to “Transfer 2.00 mL of Injection to a 50-mL glass container. Add 20.0 mL of water and 10.0 mL of Diluent. Adjust with 0.1 N sodium hydroxide or glacial acetic acid to a pH of 5.0."

3. Revise the calculation equation of pentetic acid to be consistent with the unit in the Acceptance criteria.

4. Revise the acceptance criteria from "0.027%–0.04%" to "275–400 μg/mL".

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

 The comment period for this revision ends on May 31, 2024. In the absence of any significant adverse comments, it is proposed to implement this revision via an Interim Revision Announcement with an official date of September 1, 2024.

 (SM4: G. Hsu)

 Correspondence Number—C325362