Cefotetan for Injection
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).
• 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 TestsGeneral, Sodium 191: Meets the requirements
[NoteProtect 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.
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; packing L1
Flow rate: 2 mL/min
Injection size: 20 µL
Samples: Standard solution and System suitability solution
[NoteThe relative retention times for cefotetan and cefotetan tautomer are 0.75 and 1.0, respectively, System suitability solution. ]
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
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
Acceptance criteria: 90.0%120.0%
• Uniformity of Dosage Units 905: Meets the requirements
• 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: 4.06.5, in a solution 100 mg/mL
• Water Determination, Method Ic 921: NMT 2.8%
• Other Requirements: It meets the requirements under Injections 1, Labels and Labeling.
• Packaging and Storage: Preserve as described under Injections 1, Containers for Sterile Solids.
• USP Reference Standards 11
USP Endotoxin RS
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USP35NF30 Page 2560Pharmacopeial Forum: Volume No. 35(5) Page 1122