Penicillin G Potassium Injection
» Penicillin G Potassium Injection is a sterile isoosmotic solution of Penicillin G Potassium in Water for Injection. It contains one or more suitable buffers and a tonicity-adjusting agent. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled number of Penicillin G Units.
Packaging and storage Preserve in single-dose containers, as described under Injections 1. Maintain in the frozen state.
Labeling It meets the requirements for Labeling under Injections 1. The label states that it is to be thawed just prior to use, describes conditions for proper storage of the resultant solution, and directs that the solution is not to be refrozen.
Identification The chromatogram of the Assay preparation obtained as directed in the Assay exhibits a major peak for penicillin G, the retention time of which corresponds to that exhibited in the chromatogram of the Standard preparation having a concentration of 200 Penicillin G Units per mL, obtained as directed in the Assay.
Bacterial endotoxins 85 It contains not more than 0.01 USP Endotoxin Unit per 100 Penicillin G Units.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 5.5 and 8.0.
Particulate matter 788: meets the requirements under small-volume injections.
Sodium citrate buffer Dissolve 0.8 g of sodium citrate (dihydrate) in about 150 mL of water, adjust with 0.1 N hydrochloric acid to a pH of 6.8, dilute with water to 200 mL, and mix.
Potassium phosphate buffer Dissolve 10 g of monobasic potassium phosphate in 900 mL of water, adjust with phosphoric acid to a pH of 4.15, dilute with water to 1000 mL, and mix.
Mobile phase Prepare a suitable mixture of Potassium phosphate buffer and methanol (550:450), filter through a filter of 0.5 µm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparations Prepare a standard stock solution of USP Penicillin G Potassium RS in Sodium citrate buffer containing a known concentration of about 2000 Penicillin G Units per mL. To three separate 100-mL volumetric flasks transfer 5.0, 10.0, and 15.0 mL of the standard stock solution, dilute with water to volume, and mix. These solutions contain about 100, 200, and 300 Penicillin G Units per mL, respectively.
Assay preparation 1 (where it is represented as being in a single-dose container)Allow 1 container of Injection to thaw, and mix. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with water to obtain a solution containing about 200 Penicillin G Units per mL.
Assay preparation 2 (where the label states the quantity of penicillin G in a given volume of Injection)Allow 1 container of Injection to thaw, and mix. Dilute an accurately measured volume of the Injection quantitatively with water to obtain a solution containing about 200 Penicillin G Units per mL.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 225-nm detector and a 4.6-mm × 10-cm column containing 5-µm packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation having a concentration of about 200 Penicillin G Units per mL, and record the peak responses as directed for Procedure: the tailing factor for the penicillin G peak is not more than 2, and the relative standard deviation for replicate injections is not more than 2%.
Procedure Separately inject equal volumes (about 10 µL) of the Standard preparations and the appropriate Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Plot the peak responses obtained from the Standard preparations versus concentration, in Penicillin G Units per mL, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the number, N, of Penicillin G Units in each mL of the appropriate Assay preparation. Calculate the number of Penicillin G Units in the container, or in each mL of the Injection taken by the formula:
(NL / D)in which L is the labeled number of Penicillin G Units in the container, or in each mL of Injection taken, and D is the number of Penicillin G Units in each mL of Assay preparation 1, or of Assay preparation 2, as appropriate, on the basis of the labeled number of Penicillin G Units in the container, or in each mL of the Injection taken, and the extent of dilution.
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USP32NF27 Page 3229
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.