FORSOLIDPACKAGED INSINGLE-UNITCONTAINERS :meets the requirements.

Diluent,Mobile phase,and Chromatographic system— Proceed as directed in the Assayunder Dicloxacillin Sodium.

Buffer— Use Buffer No.1(see Phosphate Buffers and Other Solutionsunder Antibiotics—Microbial Assays á81ñ).

Standard preparation— Transfer about 100mg of USP Dicloxacillin Sodium RS,accurately weighed,to a 100-mLvolumetric flask,add 20.0mLof dimethylformamide,5.0mLof alcohol,and 20mLof Buffer,and stir for 5minutes with the aid of a magnetic stirrer.Dilute with Bufferto volume,and mix.[NOTE—Use this Standard preparation promptly,or refrigerate and use on the day prepared.]

Assay preparation— Constitute Dicloxacillin Sodium for Oral Suspension as directed in the labeling.Transfer an accurately measured volume of the constituted suspension,freshly mixed and free from air bubbles,equivalent to about 125mg of dicloxacillin (C16H17Cl2N3O5S),to a 200-mLflask.Add 20.0mLof dimethylformamide and 5.0mLof alcohol,and stir for 15minutes.Add 50.0mLof Buffer,and stir for an additional 15minutes.Add another 50.0mLof Buffer,and stir for a third period of 15minutes.Centrifuge this mixture for 15minutes,and filter about 30mLof the supernatant,discarding the first 5mLof the filtrate.Use the clear filtrate as the Assay preparation.[NOTE—Use this Assay preparation promptly,or refrigerate and use on the day prepared.]

Procedure— Proceed as directed for Procedurein the Assayunder Dicloxacillin Sodium.Calculate the quantity,in mg,of dicloxacillin (C19H17Cl2N3O3S)in each mLof the constituted Dicloxacillin for Oral Suspension taken by the formula: in which Vis the volume,in mL,of constituted Dicloxacillin for Oral Suspension taken to prepare the Assay preparation;and the other terms are as defined therein.