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
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
SPECIFIC TESTS
•  Injections, Constituted Solutions 1: Meets the requirements at the time of use
•  Bacterial Endotoxins Test 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
•  Particulate Matter in Injections 788: Meets the requirements for small-volume injections
•  pH 791: 4.0–6.5, in a solution 100 mg/mL
•  Other Requirements: It meets the requirements under Injections 1, Labels and Labeling.
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve as described under Injections 1, Containers for Sterile Solids.
•  USP Reference Standards 11
USP Cefotetan RS Click to View Structure
USP Endotoxin RS
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