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Cephalexin Monographs: Notice of Intent to RevisePosting Date: 07 December 2009 The USP Monograph Development—Antibiotics Expert Committee is proposing changes for six Cephalexin monographs (Cephalexin, Cephalexin Capsules, Cephalexin Hydrochloride, Cephalexin Tablets, Cephalexin for Oral Suspension, Cephalexin Tablets for Oral Suspension), which will appear as proposed IRAs in Pharmacopeial Forum (PF) 36(1) January–February 2010. Comments with supporting data were received that 1–hydroxybenzotriazole is banned in the United States for safety reasons. The Expert Committee proposes to revise the monographs to delete the requirement for this reagent. The comment period for this revision ends on March 15, 2010. In the absence of any adverse comments, this revision will become official in the Interim Revision Announcement to USP 33–NF 28, which appears in PF 36(3) May–June 2010, with an official date of June 1, 2010. Should you have any questions, please contact Ahalya Wise, M.S., Scientific Liaison to the Monograph Development: Antibiotics Expert Committee (301–816–8161 or ). What's New
 USP recalled USP 33-NF 28 on Jan. 8, 2010. A reissue product will be available in April 2010.
PF 36(2), March-April 2010: IRAs and Errata (03/01/10) February Revision Bulletins (02/26/10) Protamine Monographs: Notice of Intent to Revise (02/26/10) New Draft Pending Standard for the month of February (02/26/10) PF 36(2), March-April 2010: Highlights (02/22/10) Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies (02/22/10) Performance of Equipment to Test Dissolution of Medications Further Assured (02/09/10) New Official Text (01/29/10) Related Resources |
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