(sef'' ue rox' eem soe' dee um).
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-[[2-furanyl(methoxyimino)acetyl]amino]-8-oxo-, monosodium salt [6R-[6,7(Z)]]-.
Sodium (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester) [56238-63-2].
» Cefuroxime Sodium contains the equivalent of not less than 855 µg and not more than 1000 µg of cefuroxime (C16H16N4O8S), 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 chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for cefuroxime, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation obtained as directed in the Assay.
B: It responds to the tests for Sodium 191.
pH 791: between 6.0 and 8.5, in a solution (1 in 10).
Water, Method I 921: not more than 3.5%.
Other requirements Where the label states that Cefuroxime Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Cefuroxime for Injection. Where the label states that Cefuroxime Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Cefuroxime for Injection.
pH 3.4 acetate buffer Transfer 50 mL of 0.1 M sodium acetate to a 1000-mL volumetric flask, dilute with 0.1 N acetic acid to volume, and mix.
Mobile phase Prepare a suitable mixture of pH 3.4 acetate buffer and acetonitrile (about 10:1). Filter through a membrane filter (1 µm or finer porosity), and degas.
Internal standard solution Prepare a solution of orcinol in water containing 1.5 mg per mL.
Standard preparation Dissolve a suitable quantity of USP Cefuroxime Sodium RS, accurately weighed, in water to obtain a solution having a known concentration of about 1 mg of cefuroxime (C16H16N4O8S) per mL. Immediately transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix. This Standard preparation contains about 0.05 mg of cefuroxime per mL.
Assay preparation Using a suitable quantity of Cefuroxime Sodium, accurately weighed, proceed as directed in the first sentence under Standard preparation. Immediately transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 15-cm column that contains 5-µm packing L15. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed under Procedure: the column efficiency determined from the analyte peak is not less than 1300 theoretical plates; the tailing factor for the analyte peak is not more than 2.0; the resolution, R, between the analyte and internal standard peaks is not less than 3.5; and the relative standard deviation for replicate injections is not more than 2.0%.
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. The relative retention times are about 0.5 for cefuroxime and 1.0 for orcinol. Calculate the quantity, in µg, of cefuroxime per mg of the Cefuroxime Sodium taken by the formula:
1000(C/M)(RU / RS)in which C is the concentration, in mg of cefuroxime (C16H16N4O8S) per mL, in the Standard preparation; M is the concentration, in mg per mL, in the Assay preparation based on the weight of Cefuroxime Sodium taken and the extent of dilution; and RU and RS are the peak response ratios of the cefuroxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2580