(sef'' men ox' eem hye'' droe klor' ide).
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-, hydrochloride (2:1), [6R-[6,7(Z)]]-.
(6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-3-[[(1-methyl-1H-tetrazol-5-yl)-thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 72-(Z)-(O-methyloxime), hydrochloride (2:1) [75738-58-8].
» Cefmenoxime Hydrochloride contains the equivalent of not less than 869 µg and not more than 1015 µg of cefmenoxime (C16H17N9O5S3) 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
Solution: 25 µg per mL.
Medium: pH 6.8 buffer (prepared as directed in the Assay).
B: The retention time of the cefmenoxime peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, both relative to the internal standard, as obtained in the Assay.
Crystallinity 695: meets the requirements.
Pyrogen 151 Where the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements, the test dose being 1.0 mL per kg of a solution in pyrogen-free sodium carbonate solution (prepared by dissolving 14.0 g of sodium carbonate, previously heated at 170 for not less than 4 hours, in 1000 mL of sterile water for injection) containing 60 mg per mL.
Sterility 71 Where the label states that it is sterile, it meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined, except to use Fluid A to each 100 mL of which has been added 2.0 g of sodium carbonate previously sterilized by heating at 180 for 2 hours.
Water, Method I 921: not more than 1.5%, the Test Preparation being prepared as directed for a hygroscopic specimen, except to use 20 mL of a mixture of formamide (previously dried over anhydrous sodium sulfate for 24 hours) and methanol (2:1), instead of methanol, to dissolve the specimen, to use two 5-mL portions of the same formamide and methanol mixture to rinse the container, and to determine the water content of the formamide and methanol mixture.
pH 6.8 buffer Dissolve 6.4 g of monobasic potassium phosphate and 18.9 g of dibasic sodium phosphate in 750 mL of water, adjust with 1 N sodium hydroxide to a pH of 6.8 ± 0.1, dilute with water to 1000 mL, and mix.
Mobile phase Prepare a suitable mixture of water, acetonitrile, and glacial acetic acid (50:10:1). Filter through a suitable filter of 0.5 µm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Internal standard solution Prepare a solution of phthalimide in methanol containing 1.5 mg per mL.
Standard preparation Transfer about 50 mg of USP Cefmenoxime Hydrochloride RS, accurately weighed, to a 50-mL volumetric flask, add 10 mL of pH 6.8 buffer, and dissolve by swirling. Dilute with Mobile phase to volume, and mix. Transfer 4.0 mL of this solution to a second 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix. This solution contains the equivalent of about 80 µg of cefmenoxime (C16H17N9O5S3) per mL.
Assay preparation Transfer about 50 mg of Cefmenoxime Hydrochloride, accurately weighed, to a 50-mL volumetric flask, add 10 mL of pH 6.8 buffer, and dissolve by swirling. Dilute with Mobile phase to volume, and mix. Transfer 4.0 mL of this solution to a second 50-mL volumetric flask, add 20.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)The liquid chromatograph is equipped with a 254-nm detector and a 4-mm × 15-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the resolution, R, between the phthalimide and the cefmenoxime peaks is not less than 2.3; the column efficiency, determined from the cefmenoxime peak, is not less than 1200 theoretical plates when calculated by the formula:
5.545(tr / Wh / 2)2the tailing factor for the cefmenoxime peak is not more than 1.6; and the relative standard deviation of replicate injections is not more than 2.0%.
Procedure [noteUse peak areas where peak responses are indicated. ] 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 cefmenoxime (C16H17N9O5S3) in each mg of the Cefmenoxime Hydrochloride taken by the formula:
(WS PS / WU)(RU / RS)in which WS is the weight, in mg, of USP Cefmenoxime Hydrochloride RS taken to prepare the Standard preparation; PS is the designated cefmenoxime (C16H17N9O5S3) content, in µg per mg, of USP Cefmenoxime Hydrochloride RS; WU is the weight, in mg, of Cefmenoxime Hydrochloride taken to prepare the Assay preparation, and RU and RS are the peak response ratios of the cefmenoxime peak to the internal standard peak obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 2549