Calcitonin Salmon Nasal Solution

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 solution of Calcitonin Salmon in a suitable diluent. It contains suitable preservatives, and is packaged in a form suitable for nasal administration so that the required dosage can be controlled as required. Each mL of Calcitonin Salmon Nasal Solution possesses an activity of NLT 80% and NMT 115% 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: 3.26 mg/mL of tetramethylammonium hydroxide pentahydrate in water and acetonitrile (9:1). Adjust with phosphoric acid to a pH of 2.5.

Solution B: 1.45 mg/mL of tetramethylammonium hydroxide pentahydrate in acetonitrile and water (3:2). Adjust with phosphoric acid to a pH of 2.5.

Mobile phase: See Table 1.

Table 1

Diluent: 7.5 mg/mL of sodium chloride, 2 mg/mL of sodium acetate, and 2 mg/mL of glacial acetic acid in water

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. 

Standard solution: 0.1 mg/mL of USP Calcitonin Salmon RS from Standard stock solution in 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 and Standard 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, System suitability solution

Tailing factor: NMT 2.5, Standard solution

Relative standard deviation: NMT 3%, Standard solution

Analysis 

Samples: Standard solution and Sample solution

Calculate the potency, in USP Calcitonin Salmon C₁₄₅H₂₄₀N₄₄O₄₉S₂ in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) x 100 

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 (mg/mL)

C_U = nominal concentration of calcitonin salmon in the Sample solution (mg/mL)

Acceptance criteria: 80%–120%

4 SPECIFIC TESTS

Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: The total aerobic microbial count is NMT 10² cfu/g, and the total combined molds and yeasts count is NMT 5 × 10¹ cfu/g. It meets the requirements for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

pH 〈791〉: 3.9–4.5

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in containers suitable for spraying the contents into the nasal cavities in a controlled individualized dosage.

Labeling: Label it to indicate that it is for intranasal administration only. The labeling also states that it has been prepared either with Calcitonin Salmon of synthetic origin or Calcitonin Salmon of rDNA origin. Label it to state that it is to be stored in a refrigerator, and that freezing is to be avoided. Label it to indicate the activity in USP Calcitonin Salmon Units/mL.

USP Reference Standards 〈11〉

USP Calcitonin Salmon RS

USP Calcitonin Salmon Related Compound A RS

N-Acetyl-cys1-calcitonin.

C₁₄₆H₂₄₃N₄₄O₄₉S₂ 3463