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Revision Bulletin

Terbinafine Hydrochloride

Posting Date:

27 February 2009


Official Date:

1 April 2009


Expert Committee:

Monograph Development–Antivirals
and Antimicrobials

In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development-Antiviral and Antimicrobials Expert Committee has approved the Terbinafine Hydrochloride Monograph Revision Bulletin. The Revision Bulletin deletes the Melting range test to align with the specifications in newly approved ANDAs. The proposed revision in Pharmacopeial Forum volume 34(5) to reflect limited approved specifications is cancelled.

The Terbinafine Hydrochloride Monograph Revision Bulletin supersedes the monograph in USP 32–NF 27 until it is printed in the USP 32–NF 27 Second Supplement, which will be released June 1, 2009.

Should you have any questions, please contact Behnam Davani, Ph.D., (301–816–8394 or bd@usp.org).

Download the Terbinafine Hydrochloride Monograph  (28KB) 

Transferred to Accelerated Revision History section:    26 February 2010