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 NLT 80% and NMT 120% of that stated on the label.
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
Solution A: Dissolve 3.26 g of tetramethylammonium hydroxide pentahydrate in 900 mL of water, add 100 mL of acetonitrile, and mix. Adjust with phosphoric acid to a pH of 2.5, pass through a filter of 0.5-µm or finer pore size, and degas.
Solution B: Dissolve 1.45 g of tetramethylammonium hydroxide pentahydrate in 400 mL of water, add 600 mL of acetonitrile, and mix. Adjust with phosphoric acid to a pH of 2.5, pass through a filter of 0.5-µm or finer pore size, and degas.
Mobile phase: See Table 1.
Standard stock solution: 1.0 mg/mL of USP Calcitonin Salmon RS in Solution A
Standard solution: 0.1 mg/mL of USP Calcitonin Salmon RS from Standard stock solution diluted with Solution 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 solution, and mix. Take 0.1 mL of this solution, add 0.9 mL of Solution A, and mix.
Sample solution: Use the solution from an undiluted Injection vial.
Detector: UV 220 nm
Column: 4.6-mm × 25-cm; packing L1
Column temperature: 65
Flow rate: 1 mL/min
Injection size: 200 µL
Sample: System suitability solution
[NoteThe relative retention times for calcitonin salmon and calcitonin salmon related compound A are 1.0 and 1.15, respectively. ]
Resolution: NLT 3 between calcitonin salmon and calcitonin salmon related compound A
Tailing factor: NMT 2.5
Relative standard deviation: NMT 3%
Samples: Standard solution and Sample solution
Calculate the potency, in USP Calcitonin Salmon Units/mL, in the portion of Injection taken:
Result = (rU/rS) × CS
Acceptance criteria: 80%120%
• Bacterial Endotoxins Test 85: NMT 0.625 USP Endotoxin Unit/USP Calcitonin Salmon Unit
• Sterility Tests 71: Meets the requirements when tested as directed in the Test for Sterility of the Product to Be Examined, Membrane Filtration
• Particulate Matter in Injections 788: Meets the requirements for small-volume injections
• pH 791: 3.94.5
• Injections 1: Meets the requirements
• 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/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.
• USP Reference Standards 11
USP Calcitonin Salmon RS
USP Endotoxin RS
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2436Pharmacopeial Forum: Volume No. 30(4) Page 1177