2569口服混悬剂头孢泊肟酯.pdfVIP

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2568 Cefpodoxime / Official Monographs USP 35 cefpodoxime proxetil R-epimer is not less than 4.0; the column proxetil R-epimer obtained from the Assay preparation and the efficiency is not less than 19,000 theoretical tes determined Standard preparation, respectively. from the cefpodoxime proxetil R-epimer peak; and the relative standard deviation for replicate injections determined from the sum of the areas of the cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer peaks is not more than 2.0%. Procedure—Inject a volume (about 20 μL) of the Test solution Cefpodoxime Proxetil for Oral into the chromatograph, record the chromatogram, and meas- Suspension ure all of the peak areas. Calculate the per centage of each im- purity in the portion of Cefpodoxime Proxetil taken by the » Cefpodoxime Proxetil for Oral Suspension con- formula: tains Cefpodoxime Proxetil and one or more 100(r / r ) buffers, suspending agents, sweeteners, flavor- i s ings, and preser vatives. When constituted as di- in which r is the peak area for each impurity; and r is the sum rected in the labeling, it contains the equivalent i s of the areas of all the peaks: not more than 3.0% of any peak of not less than 90.0 per cent and not more than at a relative retention time of about 0.86 is found; not more 110.0 percent of the labeled amoun

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