(sef'' ti zox' eem soe' dee um).
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2,3-dihydro-2-imino-4-thiazoly)(methoxyimino)acetyl]amino]-8-oxomonosodium salt, [6R-[6,7(Z)]]-.
Sodium (6R,7R)-7-[2-(2-imino-4-thiazolin-4-yl)glyoxylamido]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate 72-(Z)-(O-methyloxime) [68401-82-1].
» Ceftizoxime Sodium contains the equivalent of not less than 850 µg and not more than 995 µg of ceftizoxime (C13H13N5O5S2) 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 chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for ceftizoxime, 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.
Crystallinity 695: meets the requirements.
pH 791: between 6.0 and 8.0, in a solution (1 in 10).
Water, Method I 921: not more than 8.5%.
Other requirements Where the label states that Ceftizoxime Sodium is sterile, it meets the requirements for Sterility and Bacterial endotoxins under Ceftizoxime for Injection. Where the label states that Ceftizoxime Sodium must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Ceftizoxime for Injection.
pH 3.6 Buffer Dissolve 1.42 g of citric acid monohydrate and 1.73 g of dibasic sodium phosphate in water to obtain 1000 mL of solution.
pH 7.0 Buffer Dissolve 3.63 g of monobasic potassium phosphate and 10.73 g of dibasic sodium phosphate in water to obtain 1000 mL of solution.
Mobile phase Prepare a mixture of pH 3.6 Buffer and acetonitrile (about 9:1). Filter through a filter (1 µm or finer porosity), and degas. Adjust the composition, if necessary, to meet the performance requirements under Chromatographic system.
Internal standard solution Dissolve 1.2 g of salicylic acid in 10 mL of methanol, and dilute with pH 7.0 Buffer to obtain 200 mL of solution.
Standard preparation Dissolve a suitable quantity of USP Ceftizoxime RS, accurately weighed, in pH 7.0 Buffer to obtain a solution having a known concentration of about 1 mg of ceftizoxime (C13H13N5O5S2) per mL. Transfer 2.0 mL of this solution to a 100-mL volumetric flask, add 5.0 mL of Internal standard solution, dilute with pH 7.0 Buffer to volume, and mix. This Standard preparation contains about 0.02 mg of ceftizoxime per mL.
Assay preparation Using a suitable quantity of Ceftizoxime 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 5- to 10-µm 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 column efficiency determined from the analyte peak is not less than 2000 theoretical plates; the tailing factor for the analyte peak is not more than 2, the resolution; R, between the analyte and internal standard peaks is not less than 4; and the relative standard deviation for replicate injections is not more than 2%.
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 0.6 for ceftizoxime and 1.0 for salicylic acid. Calculate the quantity, in µg, of ceftizoxime per mg of the Ceftizoxime Sodium taken by the formula:
1000(C / M)(RU / RS)in which C is the concentration, in mg of ceftizoxime (C13H13N5O5S2) per mL, of the Standard preparation; M is the concentration, in mg per mL, of the Assay preparation based on the weight of Ceftizoxime Sodium taken and the extent of dilution; and RU and RS are the peak response ratios of the ceftizoxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2574