Type of Posting: Revision Bulletin
Posting Date: 26–Feb–2010
Official Date: 01–Sep–2010
Expert Committee: Monograph Development—Antivirals and Antimicrobials and Biopharmaceutics Expert Committee
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts and the USP Pending Monographs Guideline, the Monograph Development—Antivirals and Antimicrobials Expert Committee (MD–AA) and the Biopharmaceutics Expert Committee (BPC) have approved the Ribavirin Tablets monograph to move from a Draft Pending Monograph to official USP–NF status. At the time of approval of the official monograph, the Expert Committee incorporated changes to the Draft text in order to accommodate information provided by another FDA approved manufacturer. The following is a summary of the comments received:
Section: Definition and Assay
No. of Commenters: 2
Comment Summary #1: Commenter suggested that the definition and assay limit for ribavirin should be changed from 90.0% to 110.0% based on their approved ANDA.
Response: Comment incorporated.
Section: Organic Impurities, Procedure 1
No. of Commenters: 1
Comment Summary #2: Commenter suggested that the concentration of Standard solution should be corrected and changed from 0.02mg/mL to 1 ug/mL.
Response: Comment incorporated.
Section: Organic Impurities, Procedure 2
No. of Commenters: 1
Comment Summary #2: Commenter suggested add a second Organic Impurities (Procedure 2) procedure based on their approved ANDA.
Response: Comment incorporated.
Section: Assay and Organic Impurities, Procedure 1
No. of Commenters: 1
Comment Summary #2: Commenter suggested to use the same method for Assay and Organic Impurities, Procedure 1.
Response: Comment not incorporated. The Expert Committee is willing to consider future changes to the monograph upon receipt of supporting data.
Section: Dissolution
No. of Commenters: 1
Comment Summary #2: Commenter suggested to use UV method in the Dissolution section.
Response: Comment not incorporated. The Expert Committee is willing to consider future changes to the monograph upon receipt of supporting data.
The Ribavirin Tablets Revision Bulletin supersedes the Draft 1 Pending Monograph that was published on the USP Pending Monographs website and will be incorporated into the Second Supplement to the USP 33–NF 28 Reissue.
Should you have any questions, please contact Leonel Santos, Ph.D. (301-816-8168 or lxs@usp.org).