New USP monograph for Hypromellose Capsule shells (HPMC or veggie capsules)

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):

DEFINITION 
 
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)
 
SPECIFIC TESTS 

  • Loss on Drying <731> 

Acceptance criteria:  1.0%–13.0% 

  • Disintegration <701> 

For capsules larger than 18 mm:  Use the apparatus described in Disintegration and Dissolution <2040>.

Acceptance criteria:  30 min 

  • Microbial Enumeration Tests <61>:  The total aerobic bacteria count does not exceed 103 cfu/g, and the total combined yeasts and molds count does not exceed 102 cfu/g. 

ADDITIONAL REQUIREMENTS 

  • Packaging and Storage:  Store in tight, light-resistant containers at 15°–25° and at a relative humidity of 40%–65%, unless moisture impermeable containers are used.

For more information please access the Pharmacopoeial Forum free of charge.

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