FOR SOLIDS 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 compounds under 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 100 mg of loracarbef, based on the labeled amount per mL of the Suspension, to a 25-mL volumetric flask. Add about 20 mL of Solution A to the flask, mix, sonicate, and mix on a vortex mixer to effect dissolution. Dilute with Solution A to volume, and mix. Filter, and use the filtrate as the Test solution immediately, or refrigerate and use within 24 hours.

Procedure— Proceed as directed for Procedure in the test for Related compounds under 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 C is the concentration, in mg per mL, of USP Loracarbef RS in the Standard solution; Y is the concentration, in mg per mL, of loracarbef in the Test solution; ri is the response of any related compound obtained from the Test solution; and rS is 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%.

(Official January 1, 2007)

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

Assay preparation— Constitute 1 container 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 200 mg of Loracarbef, to a 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 10.0 mL of this solution to a second 100-mL volumetric flask, dilute with Mobile phase to volume, and mix. Pass a portion of this solution through a filter having a porosity of 0.5 µm or finer, and use the filtrate as the Assay preparation.

Procedure— Proceed as directed for Procedure in the Assay under Loracarbef. Calculate the quantity, in mg, of anhydrous loracarbef (C16H16ClN3O4) in each mL of the Loracarbef for Oral Suspension taken by the formula: in which C is the concentration, in mg per mL, of USP Loracarbef RS in the Standard preparation; P is the specified potency, in µg of anhydrous loracarbef (C16H16ClN3O4) per mg, of USP Loracarbef RS; V is the volume, in mL, of Loracarbef for Oral Suspension taken to prepare the Assay preparation; and rU and rS are the loracarbef peak responses obtained from the Assay preparation and the Standard preparation, respectively.