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 90.0percent and not more than 130.0percent 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 100,000Penicillin G Units,with 8mLof a solvent mixture consisting of acetone,0.1Mcitric acid,and 0.1Msodium citrate (2:1:1):the solution so obtained responds to the Identificationtest under Penicillin G Potassium for Injection.
Uniformity of dosage units á905ñ—
FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS :meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 5.5and 7.5,in the solution constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 1.0%.
Assay—
Standard preparation— Prepare as directed for Standard preparationunder Iodometric Assay—Antibiotics á425ñ,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 Diluentsunder Antibiotics—Microbial Assay á81ñ)to obtain a solution containing about 2000Penicillin G Units per mL.Pipet 2mLof this solution into each of two glass-stoppered,125-mLconical flasks.
Procedure— Proceed as directed for Procedureunder Iodometric Assay—Antibiotics á425ñ.Calculate the quantity,in Penicillin G Units,in each mLof the constituted solution of Penicillin G Potassium for Oral Solution taken by the formula:
(L/2D)(F)(B-I),
in which Lis the labeled quantity,in Penicillin G Units per mLin the constituted solution of Penicillin G Potassium for Oral Solution,and Dis the concentration,in Units per mL,of Penicillin Gin the Assay preparationon the basis of the labeled quantity in the constituted solution of Penicillin G Potassium for Oral Solution and the extent of dilution.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1489
Phone Number:1-301-816-8335
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