Bacampicillin Hydrochloride Tablets
» Bacampicillin Hydrochloride Tablets contain the equivalent of not less than 90.0 percent and not more than 125.0 percent of the labeled amount of ampicillin (C16H19N3O4S).
Packaging and storage— Preserve in tight containers.
USP Reference standards 11
USP Ampicillin RS Click to View Structure
USP Bacampicillin Hydrochloride RS Click to View Structure
Identification— To a portion of powdered Tablets add alcohol to obtain a solution containing the equivalent of 2 mg of ampicillin per mL: the solution so obtained responds to the Identification test under Bacampicillin Hydrochloride.
Dissolution 711
Medium: water; 900 mL.
Apparatus 2: 75 rpm.
Time: 30 minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Ampicillin RS in water to obtain a solution having a known concentration of about 0.3 mg per mL.
Procedure— Determine the amount of ampicillin (C16H19N3O4S) dissolved as directed for Procedure in the section Antibiotics—Hydroxylamine Assay under Automated Methods of Analysis 16.
Tolerances— Not less than 85% (Q) of the labeled amount of C16H19N3O4S is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 2.5%.
Assay—
Mobile phase, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Bacampicillin Hydrochloride.
Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 56 mg of ampicillin (C16H19N3O4S), to a 100-mL volumetric flask, add 90 mL of water, and sonicate for about 20 minutes. Dilute with water to volume, mix, and filter through a filter of 0.5-µm or finer porosity.
Procedure— Proceed as directed for Procedure in the Assay under Bacampicillin Hydrochloride. Calculate the quantity, in mg, of ampicillin (C16H19N3O4S) equivalent to the portion of Tablets taken by the formula:
(349.41/501.99)(100C)(rU / rS)
in which the terms are as defined therein.
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