Amoxicillin for Injectable Suspension
»Amoxicillin for Injectable Suspension is a sterile mixture of Amoxicillin and one or more suitable buffers,preservatives,stabilizers,and suspending agents.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 Containers for Sterile Solidsas described under Injections á1ñ.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— Prepare a test solution containing the equivalent of 4mg of amoxicillin per mLby adding 0.1Nhydrochloric acid to Amoxicillin for Injectable Suspension.Allow the solution to stand for 5minutes before use:the solution responds to the Identificationtest under Amoxicillin Capsules.
Bacterial endotoxins á85ñ— It contains not more than 0.25Endotoxin Unit per mg of amoxicillin.
Sterility á71ñ— It meets the requirements when tested as directed in the section Direct Inoculation of the Culture Mediumunder Test for Sterility of the Product to be Examined,except to use Fluid Thioglycollate Medium containing polysorbate 80solution (1in 200)and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube,to use Soybean–Casein Digest Medium containing polysorbate 80solution (1in 200)and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube,and to shake the tubes once daily.
pHá791ñ: between 5.0and 7.0,in the suspension constituted as directed in the labeling.
Water,Method Iá921ñ: between 11.0%and 14.0%.
Assay—
Diluent,Mobile phase,Standard preparation,andChromatographic system— Prepare as directed in the Assayunder Amoxicillin.
Assay preparation 1 (where it is represented as being in a single-dose container)—Constitute Amoxicillin for Injectable Suspension as directed in the labeling.Withdraw all of the withdrawable contents,using a hypodermic needle and syringe,and quantitatively dilute with Diluentto obtain a solution containing about 1mg of anhydrous amoxicillin per mL.Pass a portion of this solution through a suitable filter of 1-µm or finer porosity,and use the filtrate as Assay preparation 1.Use this solution within 6hours.
Assay preparation 2 (where the label states the quantity of amoxicillin in a given volume of constituted suspension)—Constitute Amoxicillin for Injectable Suspension as directed in the labeling.Quantitatively dilute an accurately measured volume of the constituted suspension with Diluentto obtain a solution containing about 1mg of anhydrous amoxicillin per mL.Pass a portion of this solution through a suitable filter of 1-µm or finer porosity,and use the filtrate as Assay preparation 2.Use this solution within 6hours.
Procedure— Proceed as directed for Procedurein the Assayunder Amoxicillin.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in the container,or in the portion of constituted Suspension taken by the formula:
(L/D)(CP/1000)(rU/rS),
in which Lis the labeled quantity,in mg,of anhydrous amoxicillin in the container,or in the volume of constituted suspension taken;Dis the concentration,in mg of anhydrous amoxicillin per mL,of Assay preparation 1or of Assay preparation 2on the basis of the labeled quantity in the container or in the portion of constituted suspension taken,respectively,and the extent of dilution;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