Bacampicillin Hydrochloride Tablets
»Bacampicillin Hydrochloride Tablets contain the equivalent of not less than 90.0percent and not more than 125.0percent of the labeled amount of ampicillin (C16H19N3O4S).
Packaging and storage— Preserve in tight containers.
Identification— To a portion of powdered Tablets add alcohol to obtain a solution containing the equivalent of 2mg of ampicillin per mL:the solution so obtained responds to the Identificationtest under Bacampicillin Hydrochloride.
Dissolution á711ñ—
Medium: water;900mL.
Apparatus 2: 75rpm.
Time: 30minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Ampicillin RSin water to obtain a solution having a known concentration of about 0.3mg per mL.
Procedure— Determine the amount of ampicillin (C16H19N3O4S)dissolved as directed for Procedurein the section Antibiotics—Hydroxylamine Assayunder Automated Methods of Analysis á16ñ.
Tolerances— Not less than 85%(Q)of the labeled amount of C16H19N3O4Sis dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 2.5%.
Assay—
Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Bacampicillin Hydrochloride.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 56mg of ampicillin (C16H19N3O4S),to a 100-mLvolumetric flask,add 90mLof water,and sonicate for about 20minutes.Dilute with water to volume,mix,and filter through a filter of 0.5-µm or finer porosity.
Procedure— Proceed as directed for Procedurein the Assayunder 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.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 213
Phone Number:1-301-816-8335