» 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.
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%.
Standard preparation Prepare as directed for Standard Preparation under Iodometric AssayAntibiotics 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 AssayAntibiotics 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.
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USP32NF27 Page 1549