23-25 March 2021
A new USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules) has been proposed in Pharmacopeial Forum (PF) 42(4), comment deadline was September 30, 2016, but the USP is still seeking for comments.
The Draft contains the following (amongst others):
Hypromellose Capsule Shell consists of two overlapping pieces (cap and body). One end of each piece is rounded and closed while the other end is open. The cap overlaps the body and maintains a tight closure. Hypromellose Capsule Shells are composed of USP Hypromellose and water, and may also contain additives such as plasticizers, surfactants, gelling agents, dispersing agents, flavoring agents, antimicrobial agents, and sweeteners. They may contain opacifiers, colorants, and/or processing aids. They may be externally coated. They may be imprinted.
IDENTIFICATION TESTS (A+B)
Acceptance criteria: 1.0%–13.0%
For capsules larger than 18 mm: Use the apparatus described in Disintegration and Dissolution <2040>.
Acceptance criteria: 30 min
For more information please access the Pharmacopoeial Forum free of charge.