U.S. PHARMACOPEIA

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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 90.0 percent and not more than 120.0 percent of the labeled amount of amoxicillin (C16H19N3O5S).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Labeling— Label it to indicate that it is for veterinary use only.
Identification— Prepare a test solution containing the equivalent of 4 mg of amoxicillin per mL by adding 0.1 N hydrochloric acid to Amoxicillin for Injectable Suspension. Allow the solution to stand for 5 minutes before use: the solution responds to the Identification test under Amoxicillin Capsules.
Bacterial endotoxins 85— It contains not more than 0.25 Endotoxin Unit per mg of amoxicillin.
Sterility 71— It meets the requirements when tested as directed in the section Direct Inoculation of the Culture Medium under Test for Sterility of the Product to be Examined, except to use Fluid Thioglycollate Medium containing polysorbate 80 solution (1 in 200) and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube, to use Soybean–Casein Digest Medium containing polysorbate 80 solution (1 in 200) and an amount of sterile penicillinase sufficient to inactivate the amoxicillin in each tube, and to shake the tubes once daily.
pH 791: between 5.0 and 7.0, in the suspension constituted as directed in the labeling.
Water, Method I 921: between 11.0% and 14.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Diluent, Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under 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 Diluent to obtain a solution containing about 1 mg 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 6 hours.
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 Diluent to obtain a solution containing about 1 mg 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 6 hours.
Procedure— Proceed as directed for Procedure in the Assay under 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 L is the labeled quantity, in mg, of anhydrous amoxicillin in the container, or in the volume of constituted suspension taken; D is the concentration, in mg of anhydrous amoxicillin per mL, of Assay preparation 1 or of Assay preparation 2 on 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., Associate Director
Expert Committee : (VET05) Veterinary Drugs 05
USP29–NF24 Page 158
Phone Number : 1-301-816-8178