Calcitonin Salmon Injection
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.
IDENTIFICATION
• The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
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
| Time (min) |
Solution A (%) |
Solution B (%) |
|---|---|---|
| 0 | 72 | 28 |
| 30 | 48 | 52 |
| 32 | 72 | 28 |
| 55 | 72 | 28 |
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.
Chromatographic system
Mode:
LC
Detector:
UV 220 nm
Column:
4.6-mm × 25-cm; packing L1
Column temperature:
65
Flow rate:
1 mL/min
Injection size:
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 = (rU/rS) × CS
| rU | = | = peak area from the Sample solution |
| rS | = | = peak area from the Standard solution |
| CS | = | = concentration of USP Calcitonin Salmon RS in the Standard solution (USP Calcitonin Salmon Units/mL) |
Acceptance criteria:
80%–120%
SPECIFIC TESTS
• Bacterial Endotoxins Test 
85
:
NMT 0.625 USP Endotoxin Unit/USP Calcitonin Salmon Unit
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
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
788:
Meets the requirements for small-volume injections
• pH 791:
3.9–4.5
791:
3.9–4.5
• Injections 1:
Meets the requirements
1:
Meets the requirements
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
11
USP Calcitonin Salmon RS
USP Calcitonin Salmon Related Compound A RS 
N-Acetyl-cys1-calcitonin.
C146H243N44O49S2 3463
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N-Acetyl-cys1-calcitonin.
C146H243N44O49S2 3463
USP Endotoxin RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Thomas A. Sigambris, M.S.
Scientific Liaison 1-301-998-6789 |
(BIO12010) Monographs - Biologics and Biotechnology 1 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2436
Pharmacopeial Forum: Volume No. 30(4) Page 1177