Penicillin G Potassium Tablets
» Penicillin G Potassium Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled number of Penicillin G Units.
Packaging and storage Preserve in tight containers.
Identification Shake a quantity of ground Tablet powder, 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), and filter: the filtrate so obtained responds to the Identification test under Penicillin G Potassium for Injection.
Medium: pH 6.0 phosphate buffer (see Buffer Solutions in the section Reagents, Indicators, and Solutions); 900 mL.
Apparatus 2: 75 rpm.
Time: 60 minutes.
Standard preparation Dissolve an accurately weighed quantity of USP Penicillin G Potassium RS in Dissolution Medium, and dilute quantitatively with the same solvent to obtain a solution having a known concentration of about 400 Penicillin G Units per mL.
Procedure Filter the solution under test, dilute with Dissolution Medium, if necessary, and proceed as directed for Procedure in the section AntibioticsHydroxylamine Assay, under Automated Methods of Analysis 16. Calculate the number of Penicillin G Units in each mL of the solution taken by the formula:
C(AU / AS)in which C is the concentration, in Penicillin G Units per mL, of the Standard preparation.
Tolerances Not less than 70% (Q) of the labeled amount of Penicillin G Units is dissolved in 60 minutes.
Uniformity of dosage units 905: meet the requirements.
Loss on drying 731 Dry about 100 mg, accurately weighed, of powdered Tablets in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 1.0% of its weight.
Standard preparation Prepare as directed for Standard preparation under Iodometric AssayAntibiotics 425, using USP Penicillin G Potassium RS.
Assay preparation Place not less than 5 Tablets in a high-speed glass blender jar containing an accurately measured volume of Buffer No. 1, and blend for 4 ± 1 minutes. Dilute an accurately measured volume of this stock solution quantitatively with Buffer No. 1 to obtain an Assay preparation 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 AssayAntibiotics 425. Calculate the quantity, in Penicillin G Units in each Tablet taken by the formula:
(L / 2D)(F)(B I)in which L is the labeled quantity, in Penicillin G Units, in each Tablet, and D is the concentration, in Units per mL, of Penicillin G in the Assay preparation on the basis of the labeled quantity in each Tablet and the extent of dilution.
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USP32NF27 Page 3230