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CEFUROXIME SODIUM

Category Antibacterial (second-generation cephalosporin).

Cefuroxime Sodium contains not less than 96.0 per cent and not more than 102.0 per cent of C16H15N4O8S.Na, calculated on the anhydrous basis.

Description White or almost white powder.

Solubility Freely soluble in water; very slightly soluble in ethanol, in chloroform and in ethyl acetate.

Contra-indication; Additional information See under Cephalexin, p. 58.

Warning It may cause transient increase in serum aspartate transaminase (AST), alanine transaminase (AST), lactate dehydrogenase (LDH) and alkaline phosphatase concentrations and jaundice.
          See also under Cephalexin, p. 58.

Packaging and storage Cefuroxime Sodium shall be kept in tightly closed containers.

Labelling The label on the container states (1) storage condition; (2) parenteral grade.

Identification
          A. The infrared absorption spectrum is concordant with the spectrum obtained from Cefuroxime Sodium RS (Appendix 2.1) or with the reference spectrum of Cefuroxime Sodium.
          B. It yields the reactions characteristic of sodium salts (Appendix 5.1).

Appearance of solution Dissolve 2.0 g in carbon dioxidefree water and dilute to 20.0 ml with the same solvent. The resulting solution is not more opalescent than reference suspension II (Appendix 4.1) and its absorbance at 450 nm is not more than 0.25 (Appendix 2.2).

pH 5.5 to 8.5, in a 1.0 per cent w/v solution (Appendix 4.11).

Specific rotation +59º to +66º, calculated on the anhydrous basis, determined in a 2.0 per cent w/v solution of acetate buffer solution pH 4.6 (Appendix 4.8).

N,N-Dimethylaniline Not more than 20 ppm (Appendix 5.16).

Related substances Carry out the test as described under Assay using Assay preparation 1, Assay preparation 2 and Resolution solution.
     In the chromatogram obtained from the Assay preparation 1, determine the percentage content of related substances by using the area of the principal peak in the chromatogram obtained from the Assay preparation 2 (1.0 per cent) as a comparison area.
     Limits
          Disregard limit 
Not more than 0.05 times the comparison area (0.05 per cent).
          Impurity A (descarbamoylcefuroxime) Not more than the comparison area (1.0 per cent).
          Any other impurity Not more than the comparison area (1.0 per cent).
          Total Not more than 3 times the comparison area (3.0 per cent).

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5)
          Mobile phase Prepare a mixture of one volume of acetonitrile and 99 volumes of an acetate buffer solution pH 3.4 prepared by dissolving 6.01 g of glacial acetic acid and 0.68 g of sodium acetate in water and diluting to 1000.0 ml with water. Make adjustments if necessary.
          Standard preparation Dissolve about 25 mg of Cefuroxime Sodium RS, accurately weighed, in water and dilute to 25.0 ml with the same solvent.
          Assay preparation 1 Dissolve about 25 mg of Cefuroxime Sodium, accurately weighed, in water and dilute to 25.0 ml with the same solvent.
          Assay preparation 2 Dilute 1.0 ml of Assay preparation 1 to 100.0 ml with water.
          Resolution solution Heat 20 ml of Standard preparation in a water-bath at 60º for 10 minutes. Cool and inject immediately.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (12.5 cm × 4.6 mm) packed with hexylsilyl group chemically bonded to porous silica microparticles (5 μm), (b) Mobile phase at a flow rate of about 1.5 ml per minute, and (c) an ultraviolet photometer set at 273 nm.
          To determine the suitability of the chromatographic system, chromatograph Resolution solution, and record the peak responses as directed under Procedure: the resolution factor between cefuroxime and descarbamoylcefuroxime is not less than 2.0. Chromatograph Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.0 per cent.
          Procedure Separately inject equal volumes (about 20 μl) of Standard preparation and Assay preparation 1 into the chromatograph, record the chromatograms, and measure the responses for the major peaks.

Calculation Calculate the content of C16H15N4O8S.Na in the Cefuroxime Sodium taken, using the declared content of C16H15N4O8S.Na in Cefuroxime Sodium RS.

Other requirements Cefuroxime Sodium intended for parenteral administration complies with the following additional requirements.
          Bacterial endotoxins When tested as described the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.10 Endotoxin Unit per mg of cefuroxime.
          Sterility Complies with the “Sterility Test” (Method I, Appendix 10.1).

MONOGRAPHS • CEFUROXIME SODIUM
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หมายเหตุ / Note : TP II 2011 PAGE 55 - 56