Calcitonin Salmon Injection
» Calcitonin Salmon Injection is a sterile solution of Calcitonin Salmon in a suitable diluent. Each mL of Calcitonin Salmon Injection possesses an activity of not less than 80 percent and not more than 110 percent of that stated on the label.
Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Avoid freezing. Store in a refrigerator.
Labeling— Label it to indicate the activity in USP Calcitonin Salmon Units per mL. The labeling states that the material is synthetic. Label it to state that it is to be stored in a refrigerator and that freezing is to be avoided.
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85— It contains not more than 0.625 USP Endotoxin Unit per USP Calcitonin Salmon Unit.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.9 and 4.5.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections 1.
Assay—
Solution A, Solution B, Mobile phase, and Chromatographic system— Prepare as directed in the Assay under Calcitonin Salmon.
Standard stock preparation— Transfer about 10.0 mg of USP Calcitonin Salmon RS, accurately weighed, into a 10-mL volumetric flask, dissolve in and dilute with Solution A to volume, and mix.
Standard preparation— Transfer 1 mL of the Standard stock preparation into a 10-mL volumetric flask, dissolve in and dilute with Solution A to volume, and mix.
Resolution solution— Dissolve the contents of a vial of USP Calcitonin Salmon Related Compound A RS and 0.4 mL of Solution A, add 0.1 mL of the Standard preparation, and mix. Take 0.1 mL of this solution, add 0.9 mL of Solution A, and mix.
Assay preparation— Use the solution from an undiluted Injection vial.
Procedure— Separately inject equal volumes (about 200 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the potency, in USP Calcitonin Salmon Units per mL, in the portion of Injection taken by the formula:
C (rU / rS)
in which C is the concentration of the Standard preparation, in USP Calcitonin Salmon Units per mL; and rU and rS are the main peak areas from the Assay preparation and Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Larry N. Callahan, Ph.D.
Senior Scientist
1-301-816-8345		 (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8345		 (MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8345		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1751
Pharmacopeial Forum: Volume No. 30(4) Page 1177