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Cefuroxime Axetil Tablets
» Cefuroxime Axetil Tablets contain the equivalent of not less than 90.0 percent and not more than 110.0 percent 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 1 is not used.
Identification— The retention times of the major peaks for cefuroxime axetil diastereoisomers A and B in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, both relative to the internal standard, as obtained in the Assay.
Dissolution 711—
TEST 1—
Medium: 0.07 N hydrochloric acid; 900 mL.
Apparatus 2: 55 rpm.
Times: 15 and 45 minutes.
Procedure— Determine the amount of cefuroxime (C16H16N4O8S) dissolved by employing UV absorption at the wavelength of maximum absorbance at about 278 nm 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 0.01 to 0.02 mg of cefuroxime (C16H16N4O8S) per mL, in the same Medium.
Tolerances— Not less than 60% (Q) of the labeled amount of C16H16N4O8S is dissolved in 15 minutes, and not less than 75% (Q) is dissolved in 45 minutes; except that where Tablets are labeled to contain the equivalent of 500 mg of cefuroxime, not less than 50% (Q) of the labeled amount of C16H16N4O8S is dissolved in 15 minutes, and not less than 70% (Q) is dissolved in 45 minutes.
TEST 2— If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.
Apparatus 2: 100 rpm.
Medium, Times, and Procedure— Proceed as directed under Test 1.
Tolerances— Not less than 60% (Q) of the labeled amount of C16H16N4O8S is dissolved in 15 minutes, and not less than 75% (Q) of the labeled amount of C16H16N4O8S is dissolved in 45 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 6.0%.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay—
0.2 M Monobasic ammonium phosphate, Mobile phase, Internal standard solution, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Cefuroxime Axetil.
Assay preparation— Finely powder not fewer than 10 Tablets, 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 2 mg 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 10 minutes. Dilute with methanol to volume, and mix. Filter a portion of this stock mixture, and transfer 5.0 mL of the filtrate to a 50-mL volumetric flask. Add 5.0 mL of Internal standard solution and 8.8 mL of methanol, dilute with 0.2 M Monobasic ammonium phosphate to volume, and mix. [NOTE—Use this Assay preparation promptly, or refrigerate and use on the day prepared.]
Procedure— Proceed as directed in the Assay under 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 V is the volume, in mL, of the volumetric flask used to prepare the stock mixture; N is the number of Tablets taken; and the other terms are as defined therein.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 442
Pharmacopeial Forum : Volume No. 29(4) Page 1014
Phone Number : 1-301-816-8223