Type of Posting: Revision Bulletin
Posting Date: 28–Oct–2011
Official Date: 01–Nov–2011
Expert Committee: Monographs—Biologics & Biotechnology 1
Reason for Revision: Compliance
In accordance with the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Biologics & Biotechnology 1 Expert Committee has revised the Calcitonin Salmon monograph:
- Definition was revised to state: “It contains NLT 90.0% and NMT 105.0% of calcitonin salmon, calculated on an acetic acid-free and anhydrous basis…” ”Dried basis” was deleted in order to match the rest of the monograph that states anhydrous. Additional wording added to the definition “1 USP Calcitonin Salmon Unit = 1 Calcitonin IU.”
- The statement “Any other impurity (NMT 0.1%)” was deleted from Impurity Table 1.
- Additional wording was added to the Acceptance criteria for the Bioidentity test: “…If the confidence interval requirement is not met, additional assays may be performed to increase the number of assays and make the confidence interval narrower. The determination of whether it meets the identity requirement should be done only after the confidence interval requirement is met. The acceptance criterion for identity is that the geometric mean is within 80% and 125% of the Assay value.”
- The sample size for Microbial Enumeration Test <61> and Tests for Specified Microorganisms <62> was reduced from 0.2 g to 25 mg. Also, the following specific wording was added to match the sponsor’s FDA submission: “It meets the requirements of the tests for absence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species and Escherichia coli.”
This Calcitonin Salmon Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 35–NF 30.
Should you have any questions, please contact Tom A. Sigambris (301-998-6789 or tzs@usp.org).