Ampicillin Soluble Powder
» Ampicillin Soluble Powder is a dry mixture of Ampicillin (as the trihydrate) and one or more suitable diluents and stabilizing agents. It contains 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 it to indicate that it is for veterinary use only.
Identification
Dissolve a quantity of it in a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a solution containing 10 mg of ampicillin per mL: the resulting solution responds to the Identification test under Ampicillin Capsules.
pH 791:
between 3.5 and 6.0, in an aqueous solution containing the equivalent of 20 mg of ampicillin per mL.
Water, Method I 921:
not more than 5.0%.
Assay
Standard preparation
Prepare as directed for Standard Preparation under Iodometric AssayAntibiotics 425, using USP Ampicillin RS.
Assay preparation
Transfer an accurately weighed quantity of Soluble Powder, equivalent to about 125 mg of ampicillin, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Procedure
Proceed as directed for Procedure under Iodometric AssayAntibiotics 425. Calculate the quantity, in mg, of ampicillin (C16H19N3O4S) in the portion of Soluble Powder taken by the formula:
(F / 20)(B I).
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1551
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