Ampicillin Boluses

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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Ampicillin Boluses

 Ampicillin Boluses contain an amount of ampicillin (as the trihydrate) equivalent to not less than 90.0 percent and not more than 120.0 percent of the labeled amount of ampicillin (C₁₆H₁₉N₃O₄S).

Packaging and storage— Preserve in tight containers.

Labeling— Label the Boluses to indicate that they are for veterinary use only.

USP Reference standards 〈11〉—

USP Ampicillin RS

Identification— Powder 1 or more Boluses, and prepare a solution containing the equivalent of 10 mg of ampicillin per mL in a mixture of acetone and 0.1 N hydrochloric acid (4:1): the resulting solution responds to the Identification test under Ampicillin Capsules.

Uniformity of dosage units 〈905〉: meet the requirements.

Loss on drying 〈731〉: not more than 5.0%.

1 Assay—

Standard preparation— Prepare as directed for Standard Preparation under Iodometric Assay—Antibiotics 〈425〉, using USP Ampicillin RS.

Assay preparation— Place not fewer than 5 Boluses in a high-speed glass blender jar containing an accurately measured volume of water, and blend for 4 ± 1 minutes. Dilute an accurately measured volume of this stock solution quantitatively and stepwise with water to obtain an Assay preparation containing about 1.25 mg of ampicillin per mL.

Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 〈425〉. Calculate the quantity, in mg, of ampicillin (C₁₆H₁₉N₃O₄S) in each Bolus taken by the formula:

(T/D)(F/2000)(B − I)

in which T is the labeled quantity, in mg, of ampicillin in each Bolus; and D is the concentration, in mg per mL, of ampicillin in the Assay preparation on the basis of the labeled quantity in each Bolus and the extent of dilution.