BRIEFING

 Hard Hypromellose Capsule Shells. Because there is no existing USP monograph for this product, a new monograph based on validated methods of analysis is proposed. The proposal for this product which appeared in PF 48(6) [Nov.–Dec. 2022] has been canceled and is being replaced with this new proposal. On the basis of comments received, the following sections are being revised:

1. Definition

2. Identification B

3. Loss on Drying

4. Disintegration

5. Microbial Enumeration Tests and Tests for Specified Microorganisms

6. Packaging and Storage

 (GCDF: M. Marques)

 Correspondence Number—C323912