Cefuroxime Axetil Tablets
»Cefuroxime Axetil Tablets contain the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of cefuroxime (C16H16N4O8S).
Packaging and storage— Preserve in well-closed containers.
Labeling— The labeling indicates whether the Tablets contain amorphous or crystalline Cefuroxime Axetil.If Tablets contain a mixture of amorphous and crystalline Cefuroxime Axetil,label to indicate the percentage of each contained therein.When more than one Dissolution test is given,the labeling states the Dissolution test used only if Test 1is not used.
Identification— The retention times of the major peaks for cefuroxime axetil diastereoisomers Aand Bin the chromatogram of the Assay preparationcorrespond to those in the chromatogram of the Standard preparation,both relative to the internal standard,as obtained in the Assay.
Dissolution á711ñ—
TEST1—
Medium: 0.07Nhydrochloric acid;900mL.
Apparatus 2: 55rpm.
Times: 15and 45minutes.
Procedure— Determine the amount of cefuroxime (C16H16N4O8S)dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 278nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Cefuroxime Axetil RS,equivalent to about 0.01to 0.02mg of cefuroxime (C16H16N4O8S)per mL,in the same Medium.
Tolerances— Not less than 60%(Q)of the labeled amount of C16H16N4O8Sis dissolved in 15minutes,and not less than 75%(Q)is dissolved in 45minutes;except that where Tablets are labeled to contain the equivalent of 500mg of cefuroxime,not less than 50%(Q)of the labeled amount of C16H16N4O8Sis dissolved in 15minutes,and not less than 70%(Q)is dissolved in 45minutes.
TEST2— If the product complies with this test,the labeling indicates that it meets USPDissolution Test 2.
Apparatus 2: 100rpm.
Medium,Times,andProcedure— Proceed as directed under Test 1.
Tolerances— Not less than 60%(Q)of the labeled amount of C16H16N4O8Sis dissolved in 15minutes,and not less than 75%(Q)of the labeled amount of C16H16N4O8Sis dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 6.0%.
Assay—
0.2M Monobasic ammonium phosphate,Mobile phase,Internal standard solution,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Cefuroxime Axetil.
Assay preparation— Finely powder not fewer than 10Tablets,accurately counted.Transfer the powder,with the aid of methanol,to a volumetric flask of such capacity that when filled to volume,the solution will contain the equivalent of about 2mg of cefuroxime (C16H16N4O8S)per mL.Add methanol to fill the volumetric flask to about half of its capacity,and shake by mechanical means for about 10minutes.Dilute with methanol to volume,and mix.Filter a portion of this stock mixture,and transfer 5.0mLof the filtrate to a 50-mLvolumetric flask.Add 5.0mLof Internal standard solutionand 8.8mLof methanol,dilute with 0.2M Monobasic ammonium phosphateto volume,and mix.[NOTE—Use this Assay preparationpromptly,or refrigerate and use on the day prepared.]
Procedure— Proceed as directed in the Assayunder Cefuroxime Axetil.Calculate the quantity,in mg,of cefuroxime (C16H16N4O8S)in each Tablet taken by the formula:
(V/12,500N)(PSWS/100)(100–K)(RU/RS),
in which Vis the volume,in mL,of the volumetric flask used to prepare the stock mixture;Nis the number of Tablets taken;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 408
Pharmacopeial Forum:Volume No.29(4)Page 1014
Phone Number:1-301-816-8335