Cloxacillin Sodium for Oral Solution
»Cloxacillin Sodium for Oral Solution is a dry mixture of Cloxacillin Sodium and one or more suitable buffers,colors,flavors,and preservatives.It contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of cloxacillin (C19H18ClN3O5S).
Packaging and storage— Preserve in tight containers.
Uniformity of dosage units á905ñ—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 5.0and 7.5,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 1.0%.
Assay—
Buffer,Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Cloxacillin Sodium.
Assay preparation— Constitute Cloxacillin Sodium for Oral Solution as directed in the labeling.Transfer an accurately measured volume of the resulting solution,equivalent to about 125mg of cloxacillin,to a 250-mLvolumetric flask,dilute with Bufferto volume,mix,and stir for 15minutes.Filter about 25mLof this mixture,discarding the first 5mLof the filtrate.Use the clear filtrate as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assayunder Cloxacillin Sodium.Calculate the quantity,in mg,of cloxacillin (C19H18ClN3O5S)in the portion of Cloxacillin Sodium for Oral Solution taken by the formula:
0.25CE(rU/rS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 526
Pharmacopeial Forum:Volume No.28(4)Page 1092
Phone Number:1-301-816-8335
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