Amoxicillin for Oral Suspension
»Amoxicillin for Oral Suspension contains the equivalent of not less than 90.0percent and not more than 120.0percent of the labeled amount of amoxicillin (C16H19N3O5S).It contains one or more suitable buffers,colors,flavors,preservatives,stabilizers,sweeteners,and suspending agents.
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Identification— Prepare a solution containing the equivalent of 4mg of amoxicillin by adding 0.1Nhydrochloric acid to a portion of Amoxicillin for Oral Suspension.Allow the solution to stand for 5minutes before use:the solution responds to theIdentificationtest underAmoxicillin Capsules.
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 suspension constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 3.0%,except where it is labeled as containing 80mg of amoxicillin per mLafter constitution,the limit is not more than 4.0%.
Assay—
Diluent,Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in theAssayunderAmoxicillin.
Assay preparation— Dilute an accurately measured volume of Amoxicillin for Oral Suspension,constituted as directed in the labeling,freshly mixed and free from air bubbles,quantitatively and stepwise inDiluentto obtain a solution containing about 1mg of anhydrous amoxicillin per mL.Filter a portion of this solution through a suitable filter of 1-µm or finer porosity,and use the filtrate as theAssay preparation.Use this solution within 6hours.
Procedure— Proceed as directed forProcedurein theAssayunderAmoxicillin.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in each mLof the constituted Oral Suspension taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg per mL,of anhydrous amoxicillin in the constituted Amoxicillin for Oral Suspension;Dis the concentration,in mg per mL,of anhydrous amoxicillin in theAssay preparationon the basis of the labeled quantity in the constituted Amoxicillin for Oral Suspension and the extent of dilution;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 145
Pharmacopeial Forum:Volume No.27(6)Page 3243
Phone Number:1-301-816-8335