FORSOLIDS PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Solution A,Solution B,Mobile phase,System suitability solution,Standard solution,and Chromatographic system— Proceed as directed in the test for Related compoundsunder Loracarbef.

Test solution— Constitute a container of Loracarbef for Oral Suspension as directed in the labeling.Transfer an accurately measured portion of the Suspension thus obtained,equivalent to 100mg of loracarbef,based on the labeled amount per mLof the Suspension,to a 25-mLvolumetric flask.Add about 20mLof Solution Ato the flask,mix,sonicate,and mix on a vortex mixer to effect dissolution.Dilute with Solution Ato volume,and mix.Filter,and use the filtrate as the Test solutionimmediately,or refrigerate and use within 24hours.

Procedure— Proceed as directed for Procedurein the test for Related compoundsunder Loracarbef,except to omit the injection of the Phenylglycine solution.Calculate the percentage of each related compound in the Suspension taken by the formula: in which Cis the concentration,in mg per mL,of USP Loracarbef RSin the Standard solution;Yis the concentration,in mg per mL,of loracarbef in the Test solution;riis the response of any related compound obtained from the Test solution;and rSis the loracarbef response obtained from the Standard solution:not more than 1.0%of any individual related compound is found,and the sum of all related compounds is not more than 4.0%.

Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Loracarbef.

Assay preparation— Constitute 1container of Loracarbef for Oral Suspension as directed in the labeling.Transfer an accurately measured volume of Loracarbef for Oral Suspension,freshly mixed and free from air bubbles,equivalent to about 200mg of Loracarbef,to a 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Transfer 10.0mLof this solution to a second 100-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.Pass a portion of this solution through a filter having a porosity of 0.5µm or finer,and use the filtrate as the Assay preparation.

Procedure— Proceed as directed for Procedurein the Assayunder Loracarbef.Calculate the quantity,in mg,of anhydrous loracarbef (C16H16ClN3O4)in each mLof the Loracarbef for Oral Suspension taken by the formula: in which Cis the concentration,in mg per mL,of USP Loracarbef RSin the Standard preparation;Pis the specified potency,in µg of anhydrous loracarbef (C16H16ClN3O4)per mg,of USP Loracarbef RS;Vis the volume,in mL,of Loracarbef for Oral Suspension taken to prepare the Assay preparation;and rUand rSare the loracarbef peak responses obtained from the Assay preparationand the Standard preparation,respectively.