Penicillin V Benzathine Oral Suspension, chemical structure, molecular formula, Reference Standards

Penicillin V Benzathine Oral Suspension

»Penicillin V Benzathine Oral Suspension contains not less than 90.0percent and not more than 120.0percent of the labeled number of Penicillin V Units per mL.It contains one or more suitable buffers,colors,dispersants,flavors,and preservatives.

Packaging and storage— Preserve in tight containers,and store in a refrigerator.

Labeling— It may be labeled in terms of the weight of penicillin Vcontained therein,in addition to or instead of Units,on the basis that 1600Penicillin V Units are equivalent to 1mg of penicillin V.

USP Reference standards á11ñ— USP Penicillin V Potassium RS.

Uniformity of dosage units á905ñ—

FORSUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS :meets the requirements.

Deliverable volume á698ñ: meets the requirements.

pHá791ñ: between 6.0and 7.0.

Assay—

Standard preparation— Prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ,using USP Penicillin V Potassium RS.

Assay preparations— Dilute an accurately measured volume of Oral Suspension,freshly mixed and free from air bubbles,quantitatively with 1.0Nsodium hydroxide to obtain a solution containing 2000Penicillin V Units per mL.Pipet 2mLof this solution into a glass-stoppered,125-mLconical flask,and use as the Assay preparationfor Inactivation and titration.Dilute an accurately measured volume of Oral Suspension quantitatively with water to obtain a suspension containing 2000Penicillin V Units per mL.Pipet 2mLof this suspension into a glass-stoppered,125-mLconical flask,and use as the Assay preparationfor the Blank determination.

Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ,except in the Inactivation and titrationto omit the addition of 2.0mLof 1.0Nsodium hydroxide.Calculate the quantity,in Penicillin V Units,in each mLof the Oral Suspension taken by the formula:

(T/2D)F(B-I),

in which Tis the labeled quantity,in Penicillin V Units per mL,in the Oral Suspension,and Dis the concentration,in Penicillin V Units per mL,in the Assay preparationfor Inactivation and titrationon the basis of the volume of Oral Suspension taken and the extent of dilution.

Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1499

Phone Number:1-301-816-8335