Penicillin G Potassium for Oral Solution
» Penicillin G Potassium for Oral Solution is a dry mixture of Penicillin G Potassium and one or more suitable buffers, colors, diluents, flavors, and preservatives. It contains not less than 90.0 percent and not more than 130.0 percent of the labeled number of Penicillin G Units when constituted as directed in the labeling.
Packaging and storage— Preserve in tight containers.
Identification— Shake a portion of it, equivalent to about 100,000 Penicillin G Units, with 8 mL of a solvent mixture consisting of acetone, 0.1 M citric acid, and 0.1 M sodium citrate (2:1:1): the solution so obtained responds to the Identification test under Penicillin G Potassium for Injection.
Uniformity of dosage units 905
For solid packaged in single-unit containers : meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 5.5 and 7.5, in the solution constituted as directed in the labeling.
Water, Method I 921: not more than 1.0%.
Assay—
Standard preparation— Prepare as directed for Standard preparation under Iodometric Assay—Antibiotics 425, using USP Penicillin G Potassium RS.
Assay preparation— Dilute an accurately measured volume of solution of Penicillin G Potassium for Oral Solution, constituted as directed in the labeling, quantitatively and stepwise with Buffer No. 1 (see Media and Diluents under Antibiotics—Microbial Assay 81) to obtain a solution containing about 2000 Penicillin G Units per mL. Pipet 2 mL of this solution into each of two glass-stoppered, 125-mL conical flasks.
Procedure— Proceed as directed for Procedure under Iodometric Assay—Antibiotics 425. Calculate the quantity, in Penicillin G Units, in each mL of the constituted solution of Penicillin G Potassium for Oral Solution taken by the formula:
(L / 2D)(F)(B I)
in which L is the labeled quantity, in Penicillin G Units per mL in the constituted solution of Penicillin G Potassium for Oral Solution, and D is the concentration, in Units per mL, of Penicillin G in the Assay preparation on the basis of the labeled quantity in the constituted solution of Penicillin G Potassium for Oral Solution and the extent of dilution.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 3230