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Cephalexin Monographs

Type of Posting: Notice of Intent to Revise

Posting Date: 07–Dec–2009

Reposting Date: 30–Jun–2010

The USP Monograph Development—Antibiotics Expert Committee has proposed changes for six Cephalexin monographs (Cephalexin, Cephalexin Capsules, Cephalexin Hydrochloride, Cephalexin Tablets, Cephalexin for Oral Suspension, Cephalexin Tablets for Oral Suspension), which appeared as proposed Interim Revision Announcements (IRAs) in Pharmacopeial Forum (PF) 36(1) January–February 2010.

Comments were received that 1–hydroxybenzotriazole is banned in the United States for safety reasons. The Expert Committee proposed to revise the monographs to delete the requirement for this reagent.

The revised text will become official as Interim Revision Announcements in PF 36(5) September–October 2010, with an official date of October 1, 2010. No adverse comments were received regarding the revised text and these monographs will become official as proposed in PF.

Should you have any questions, please contact Ahalya Wise, M.S., Scientific Liaison to the Monograph Development: Antibiotics Expert Committee (301-816-8161 or