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Atorvastatin Calcium

Type of Posting: Notice of Intent to Revise

Posting Date: 25–Feb–2011

Official Date: Revision Bulletin, Date To Be Determined

Expert Committee: Monographs—Small Molecules 3

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 3 Expert Committee intends to revise the Atorvastatin Calcium monograph to include specifications for Water Determination that accommodate different polymorphic forms, and to add Procedure 2 for Organic Impurities and Enantiomeric purity tests using a flexible monograph approach, to capture the potential impurities from a different synthetic route.

It is anticipated that the proposed revision will be published as a Revision Bulletin at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.

Should you have questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or