U.S. PHARMACOPEIA

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Penicillin V Benzathine Oral Suspension
» Penicillin V Benzathine Oral Suspension contains not less than 90.0 percent and not more than 120.0 percent 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 V contained therein, in addition to or instead of Units, on the basis that 1600 Penicillin V Units are equivalent to 1 mg of penicillin V.
Uniformity of dosage units 905—
FOR SUSPENSION PACKAGED IN SINGLE-UNIT CONTAINERS : meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 6.0 and 7.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Standard preparation— Prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425, 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 1.0 N sodium hydroxide to obtain a solution containing 2000 Penicillin V Units per mL. Pipet 2 mL of this solution into a glass-stoppered, 125-mL conical flask, and use as the Assay preparation for Inactivation and titration. Dilute an accurately measured volume of Oral Suspension quantitatively with water to obtain a suspension containing 2000 Penicillin V Units per mL. Pipet 2 mL of this suspension into a glass-stoppered, 125-mL conical flask, and use as the Assay preparation for the Blank determination.
Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425, except in the Inactivation and titration to omit the addition of 2.0 mL of 1.0 N sodium hydroxide. Calculate the quantity, in Penicillin V Units, in each mL of the Oral Suspension taken by the formula:
(T / 2D)F(B I),
in which T is the labeled quantity, in Penicillin V Units per mL, in the Oral Suspension, and D is the concentration, in Penicillin V Units per mL, in the Assay preparation for Inactivation and titration on the basis of the volume of Oral Suspension taken and the extent of dilution.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1670
Phone Number : 1-301-816-8223