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Revision Bulletin

Pantoprazole Sodium Delayed-Release Tablets

Posting Date: 30 October 2009
Official Date: 1 December 2009
Expert Committee: Biopharmaceutics


In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Biopharmaceutics Expert Committee has revised the monograph by the inclusion of a Dissolution Test 4 for a new generic product approved by the U.S. Food and Drug Administration.

The Pantoprazole Sodium Delayed-Release Tablets Revision Bulletin supersedes the monograph in USP 32-NF 27 until it is printed in the USP 33–NF 28 First Supplement which will be released 1 February 2010 and becomes official 1 August 2010.

Should you have any questions, please contact Margareth Marques, Ph.D., (301–816–8106 or .

Download the Pantoprazole Sodium Delayed-Release Tablets Revision Bulletin  (232KB)

What's New

Changes to the Dissolution Performance Verification Test (11/20/09)

PF 35(6) Errata (10/30/09)

New official Text for October: 15 Revisions Bulletins (10/30/09)

Pending Standards for the month of October (10/30/09)

PF 35(6), November-December 2009: Highlights and Stimuli Articles (10/23/09)

Admission Criteria and Safety Classification for Dietary Supplements Guideline (10/22/09)

Elemental Impurities Hot Topics information updated (10/13/09)

General Chapter <1151> Pharmaceutical Dosage Forms (10/06/09)

Heparin Hot Topics information updated (10/02/09)

PF Redesign

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