Type of Posting: Notice of Intent to Revise
Posting Date: 01–Oct–2013
Targeted Official Date: Interim Revision Announcement; 01–May–2014
Expert Committee: Monographs—Biologics & Biotechnology 1
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 Monographs—Biologics & Biotechnology 1 Expert Committee intends to revise the Calcitonin Salmon Injection and Calcitonin Salmon Nasal Spray monographs to reflect the released USP reference standards. The proposed revisions are:
1. Assay
Current monograph instructions:
A. System suitability solution: Dissolve the contents of a vial of USP Calcitonin Salmon Related Compound A RS in 0.4 mL of Solution A, add 0.1 mL of the Standard preparation, and mix
Proposed revised wording:
A. System suitability solution: Prepare a solution in Solution A containing about 0.2 mg/mL of USP Calcitonin Salmon Related Compound A RS and 0.2 mg/mL of USP Calcitonin Salmon RS.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 39(6) [Nov.–Dec. 2013] pursuant to section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Dale R. Schmidt, Science and Standards Liaison at (301-230-7458 or dls@usp.org).