BRIEFING

 Ethylcellulose Dispersion Type B. This proposal is based on the version of the monograph official as of May 1, 2020. The proposal for this excipient, which appeared in PF 49(3) [May–Jun. 2023], has subsequently been canceled and is being replaced with a new proposal based on additional expert committee reviews and additional data received. It is proposed to change the Sample preparation procedure of the Viscosity—Rotational Methods test. The acceptance criteria of the Viscosity—Rotational Methods test from the PF 49(3) proposal is changed from 10–100 mPa·s to 10–60 mPa·s.

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

 (CE: A. Chang)

 Case ID—SUB-1248