Ampicillin for Oral Suspension, chemical structure, molecular formula, Reference Standards

Ampicillin for Oral Suspension

»Ampicillin for Oral Suspension contains an amount of Ampicillin (anhydrous or as the trihydrate)equivalent to not less than 90.0percent and not more than 120.0percent of the labeled amount of C16H19N3O4S,when constituted as directed.It contains one or more suitable buffers,colors,flavors,preservatives,and sweetening ingredients.

Packaging and storage— Preserve in tight containers.

Labeling— Label it to indicate whether the ampicillin therein is in the anhydrous form or is the trihydrate.

USP Reference standards á11ñ— USP Ampicillin RS.

Identification— Dissolve a quantity in a mixture of acetone and 0.1Nhydrochloric acid (4:1)to obtain a solution containing 5mg of ampicillin per mL:the resulting solution responds to the Identificationtest under Ampicillin Capsules.

Uniformity of dosage units á905ñ—

FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 5.0and 7.5,in the suspension constituted as directed in the labeling.

Water,Method Iá921ñ: not more than 2.5%,or not more than 5.0%if it contains ampicillin trihydrate and contains the equivalent of 100mg of ampicillin per mLwhen constituted as directed in the labeling.

Assay—

Standard preparation— Prepare as directed for Standard Preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Ampicillin RS.

Assay preparation— Dilute an accurately measured volume of Ampicillin for Oral Suspension,constituted as directed in the labeling,freshly mixed and free from air bubbles,quantitatively and stepwise with water to obtain a solution containing about 1.25mg of ampicillin per mL.

Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in mg,of C16H19N3O4Sin each mLof the constituted suspension prepared from Ampicillin for Oral Suspension taken by the formula:

(T/D)(F/2000)(B-I),

in which Tis the labeled quantity,in mg per mL,of ampicillin in the constituted suspension;and Dis the concentration,in mg per mL,of ampicillin in the Assay preparationon the basis of the labeled quantity in the constituted suspension 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

Phone Number:1-301-816-8335