Amoxicillin Oral Suspension
»Amoxicillin Oral Suspension is a suspension of Amoxicillin in Soybean Oil.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of amoxicillin (C16H19N3O5S).
Packaging and storage— Preserve in multiple-dose containers equipped with a suitable dosing pump.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— Shake a portion of Oral Suspension with a mixture of acetone and 0.1Nhydrochloric acid (4:1)to obtain a solution containing about 1mg of amoxicillin per mL.The solution responds to the Identificationtest under Amoxicillin Capsules.
Water,Method Iá921ñ: not more than 2.0%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Assay—
Standard preparation— Prepare as directed for Standard Preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Amoxicillin RS.
Assay preparation— Using the dosing pump,deliver a number of doses of Oral Suspension,equivalent to about 250mg of amoxicillin,to a separator containing 100mLof hexanes,and shake vigorously.Add 140mLof water,and shake for 5minutes.Allow the layers to separate,and drain the lower,aqueous layer into a 250-mLvolumetric flask.Repeat the extraction with two 50-mLportions of water.Combine the aqueous extracts in the volumetric flask,dilute with water to volume,and mix.
Procedure— Proceed with Oral Suspension as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,using USP Amoxicillin RS.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in each dose of Oral Suspension taken by the formula:
(250/N)(F/2000)(B-I),
in which Nis the number of doses taken,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 145
Phone Number:1-301-816-8178