Calcitonin Salmon Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

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.

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Procedure

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.

Table 1

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. Take 0.1 mL of this solution, add 0.9 mL of Solution A, and mix.

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

Sample solution: Use the solution from an undiluted Injection vial.

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm × 25-cm; packing L1

Column temperature: 65°

Flow rate: 1 mL/min

Injection volume: 200 µL

System suitability 

Sample: System suitability solution

[Note—The relative retention times for calcitonin salmon and calcitonin salmon related compound A are 1.0 and 1.15, respectively.]

Suitability requirements

Resolution: NLT 3 between calcitonin salmon and calcitonin salmon related compound A

Tailing factor: NMT 2.5

Relative standard deviation: NMT 3%

Analysis 

Samples: Standard solution and Sample solution

Calculate the potency, in USP Calcitonin Salmon Units/mL, in the portion of Injection taken:

Result = (r_U/r_S) × C_S  

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

C_S = concentration of USP Calcitonin Salmon RS in the Standard solution (USP Calcitonin Salmon Units/mL)

Acceptance criteria: 80%–120%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 0.625 USP Endotoxin Units/USP Calcitonin Salmon Unit

Sterility Tests 〈71〉: Meets the requirements when tested as directed in 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〉: 3.9–4.5

Injections and Implanted Drug Products 〈1〉: Meets the requirements

5 ADDITIONAL 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 Calcitonin Salmon Related Compound A RS

N-Acetyl-cys1-calcitonin.

C₁₄₆H₂₄₃N₄₄O₄₉S₂ 3463