Cefotetan for Injection
DEFINITION
Cefotetan for Injection contains an amount of Cefotetan Disodium equivalent to NLT 90.0% and NMT 120.0% of the labeled amount of cefotetan (C17H17N7O8S4).
IDENTIFICATION
• A.
The retention time of the major peak of the appropriate Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
• B. Identification Tests—General, Sodium 
191
:
Meets the requirements
191:
Meets the requirements
ASSAY
• Procedure
[Note—Protect the Standard solution, the System suitability solution, Sample solution A, and Sample solution B from light, and use within 2 h. ]
Solution A:
Acetonitrile, methanol, and water (1:1:18)
Mobile phase:
Acetonitrile, methanol, glacial acetic acid, and 0.1 M phosphoric acid (105:105:100:1700)
Standard solution:
20 mg of USP Cefotetan RS in a 100-mL volumetric flask. Add 5 mL of methanol, swirl for several min, add 5 mL of acetonitrile, and swirl until dissolved. Dilute with water to volume.
System suitability solution:
10 mL of Standard solution in a glass-stoppered flask containing a few mg of magnesium carbonate. Sonicate for 10 min. If the solution is not turbid, add a few more mg of magnesium carbonate, and repeat the sonication. Filter the turbid solution through a filter of 0.5-µm or finer pore size. Use the clear filtrate.
Sample solution A (where the package is represented as being in a single-dose container):
Constitute Cefotetan for Injection as directed in the labeling. Withdraw all of the withdrawable contents, and quantitatively dilute with Solution A to obtain a solution containing the equivalent of 200 µg/mL of cefotetan.
Sample solution B (where the label states the quantity of cefotetan in a given volume of constituted solution):
Constitute Cefotetan for Injection as directed in the labeling. Dilute an aliquot of the constituted solution with Solution A to obtain a solution containing the equivalent of 200 µg/mL of cefotetan.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 25-cm; packing L1
Flow rate:
2 mL/min
Injection size:
20 µL
System suitability
Samples:
Standard solution and System suitability solution
[Note—The relative retention times for cefotetan and cefotetan tautomer are 0.75 and 1.0, respectively, System suitability solution. ]
Suitability requirements
Resolution:
NLT 2.0 between cefotetan and cefotetan tautomer, System suitability solution
Column efficiency:
NLT 1500 theoretical plates, Standard solution
Tailing factor:
NMT 1.5, Standard solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution, and Sample solution A or Sample solution B
Calculate the percentage of C17H17N7O8S4 withdrawn from the container, or in the portion of solution taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from Sample solution A or Sample solution B |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Cefotetan RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of cefotetan in Sample solution A or Sample solution B (µg/mL) |
Acceptance criteria:
90.0%–120.0%
PERFORMANCE TESTS
• Uniformity of Dosage Units 905:
Meets the requirements
905:
Meets the requirements
SPECIFIC TESTS
• Injections, Constituted Solutions 1:
Meets the requirements at the time of use
1:
Meets the requirements at the time of use
• Bacterial Endotoxins Test 85:
NMT 0.17 USP Endotoxin Unit/mg of cefotetan
85:
NMT 0.17 USP Endotoxin Unit/mg of cefotetan
• Sterility Tests 71:
Meets the requirements when tested as directed for Test for Sterility of the Product to Be Examined, Membrane Filtration
71:
Meets the requirements when tested as directed for 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:
4.0–6.5, in a solution 100 mg/mL
791:
4.0–6.5, in a solution 100 mg/mL
• Water Determination, Method Ic 921:
NMT 2.8%
921:
NMT 2.8%
• Other Requirements:
It meets the requirements under Injections 1, Labels and Labeling.
1, Labels and Labeling.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve as described under Injections 1, Containers for Sterile Solids.
1, Containers for Sterile Solids.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 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 2560
Pharmacopeial Forum: Volume No. 35(5) Page 1122