(sef'' oh per' a zone soe' dee um).
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino](4-hydroxyphenyl)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-, monosodium salt, [6R-[6,7(R*)]]-.
Sodium (6R,7R)-7-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-2-(p-hydroxyphenyl)acetamido-3-[[(1-methyl-H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate [62893-20-3].
» Cefoperazone Sodium contains the equivalent of not less than 870 µg and not more than 1015 µg of cefoperazone (C25H27N9O8S2) per mg, calculated on the anhydrous basis.
Packaging and storage Preserve in tight containers.
Labeling Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 11
USP Endotoxin RS
A: The retention time of the major peak for cefoperazone in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
B: It responds to the tests for Sodium 191.
Crystallinity 695: meets the requirements.
pH 791: between 4.5 and 6.5, in a solution (1 in 4).
Water, Method I 921: not more than 5.0%.
Other requirements Where the label states that Cefoperazone Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Cefoperazone for Injection. Where the label states that Cefoperazone Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Cefoperazone for Injection.
Mobile phase Place 14 mL of triethylamine and 5.7 mL of glacial acetic acid in a 100-mL volumetric flask, dilute with water to volume, and mix. Prepare a suitable mixture of water, acetonitrile, 1 N acetic acid, and this solution (876:120:2.8:1.2). Filter through a membrane filter (1-µm or finer porosity), and degas.
Standard preparation Dissolve a suitable quantity of USP Cefoperazone Dihydrate RS, accurately weighed, in Mobile phase to obtain a solution having a known concentration of about 0.16 mg of cefoperazone (C25H27N9O8S2) per mL.
Assay preparation Using a suitable quantity of Cefoperazone Sodium, accurately weighed, proceed as directed under Standard preparation.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 254-nm detector and a 4.0-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.0%, and the tailing factor is not more than 1.5.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in µg of cefoperazone per mg, of the Cefoperazone Sodium taken by the formula:
1000(C / M)(rU / rS)in which C is the concentration, in mg of cefoperazone (C25H27N9O8S2) per mL, of the Standard preparation; M is the concentration, in mg per mL, of the Assay preparation based on the weight of Cefoperazone Sodium taken and the extent of dilution; and rU and rS are the peak responses from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2554