Ampicillin Tablets
»Ampicillin Tablets contain an amount of Ampicillin (anhydrous form or trihydrate form)equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of ampicillin (C16H19N3O4S).
Packaging and storage— Preserve in tight containers,and store at controlled room temperature.
Labeling— Label the Tablets to indicate whether the ampicillin therein is in the anhydrous form or is the trihydrate.Label chewable Tablets to indicate that they are to be chewed before swallowing.Tablets intended for veterinary use only are so labeled.
Identification— Powder 1or more Tablets,and prepare a solution containing 5mg of ampicillin per mLin a mixture of acetone and 0.1Nhydrochloric acid (4:1):the resulting solution meets the requirements for the Identificationtest under Ampicillin Capsules.
Dissolution,Procedure for a Pooled Sample á711ñ—
Medium: water;900mL.
Apparatus 1: 100rpm.
Time: 45minutes.
Standard preparation— Dissolve an accurately weighed quantity of USP Ampicillin RSin water to obtain a solution having a known concentration of about L/900mg per mL,Lbeing the labeled amount,in mg,of ampicillin per Tablet.
Procedure— Proceed as directed for Procedurein the section Antibiotics—Hydroxylamine Assayunder Automated Methods of Analysis á16ñ,using a filtered portion of the solution under test as the Assay preparation.Calculate the quantity,in mg,of C16H19N3O4Sdissolved by the formula:
0.9CP(AU/AS).
Tolerances— Not less than 75%(Q)of the labeled amount of C16H19N3O4Sis dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 4.0%where nonchewable Tablets contain anhydrous Ampicillin;between 9.5%and 12.0%where nonchewable Tablets contain Ampicillin trihydrate;not more than 3.0%where chewable Tablets contain anhydrous Ampicillin;not more than 5.0%where chewable Tablets contain Ampicillin trihydrate;and not more than 13.0%where Tablets are labeled for veterinary use only and contain Ampicillin trihydrate.
Assay—
Standard preparation— Prepare as directed for Standard Preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Ampicillin RS.
Assay preparation— Place not fewer than 5Tablets in a high-speed glass blender jar containing an accurately measured volume of water,and blend for 4±1minutes.Dilute an accurately measured volume of this stock solution with water to obtain an Assay preparationcontaining about 1.25mg of ampicillin per mL.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in mg,of ampicillin (C16H19N3O4S)in each Tablet taken by the formula:
(T/D)(F/2000)(B-I),
in which Tis the labeled quantity,in mg,of ampicillin in each Tablet;and Dis the concentration,in mg per mL,of ampicillin in the Assay preparationon the basis of the labeled quantity in each Tablet and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 154
Pharmacopeial Forum:Volume No.30(1)Page 56
Phone Number:1-301-816-8335