Penicillin G Sodium for Injection
»Penicillin G Sodium for Injection is sterile Penicillin G Sodium or a sterile mixture of Penicillin G Sodium and not less than 4.0percent and not more than 5.0percent of Sodium Citrate,of which not more than 0.15percent may be replaced by Citric Acid.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of penicillin G.In addition,where it contains Sodium Citrate it has a potency of not less than 1420and not more than 1667Penicillin G Units per mg.
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— It responds to the Identificationtest under Penicillin G Potassium for Injection.
Crystallinity á695ñ: meets the requirements.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
Bacterial endotoxins á85ñ— It contains not more than 0.01USP Endotoxin Unit per 100Penicillin G Units.
Change to read:
pHá791ñ: between 5.0and 7.5,USP28in a solution containing 60mg per mL,except where it is labeled as containing sodium citrate it is between 6.0and 7.5.USP28
Loss on drying á731ñ— Dry about 100mg,accurately weighed,in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 1.5%of its weight.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Uniformity of Dosage Units á905ñand Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Proceed as directed in the Assayunder Penicillin G Sodium.
Assay preparation 1(where it is represented as being in a single-dose container)— Constitute Penicillin G Sodium for Injection as directed in the labeling.Withdraw all of the withdrawable contents,using a hypodermic needle and syringe,and quantitatively dilute with water to obtain a solution containing about 160Penicillin G Units per mL.
Assay preparation 2(where the label states the quantity of penicillin Gin a given volume of constituted solution)— Constitute Penicillin G Sodium for Injection as directed in the labeling.Quantitatively dilute an accurately measured volume of the constituted solution with water to obtain a solution containing about 160Penicillin G Units per mL.
Assay preparation 3(where it contains Sodium Citrate)— Transfer about 50mg of the Penicillin G Sodium for Injection,accurately weighed,to a 500-mLvolumetric flask,add about 400mLof water,and shake to dissolve.Dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Penicillin G Sodium.Calculate the number of Penicillin G Units in the container or in the portion of constituted solution taken by the formula:
(L/D)(PWS/50)(rU/rS),
in which Lis the labeled quantity of Penicillin G Units in the container or in the volume of constituted solution taken;Dis the concentration,in Penicillin G Units per mL,of Assay preparation 1or Assay preparation 2,on the basis of the labeled quantity in the container or in the portion of constituted solution taken and the extent of dilution;Pis the specified potency,in Penicillin G Units per mg,of USP Penicillin G Potassium RS;WSis the weight,in mg,of USP Penicillin G Potassium RStaken to prepare the Standard preparation;and rUand rSare the penicillin Gpeak responses obtained from the Assay preparationand the Standard preparation,respectively.Calculate the potency,in Penicillin G Units per mg,of the Penicillin G Sodium for Injection taken by the formula:
10(WS/WU)(P)(rU/rS),
in which WSand WUare the weights,in mg,of USP Penicillin G Potassium RSand Penicillin G Sodium for Injection taken to prepare the Standard preparationand Assay preparation 3,respectively;and the other terms are as defined above.Perform the above procedure on 10containers (where it is represented as being in a single-dose container)and,if necessary,on 10containers (where the label states the quantity of penicillin Gin a given volume of constituted solution).Use the individual results to determine the Uniformity of dosage unitsand the average thereof as the Assayvalue.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1496
Pharmacopeial Forum:Volume No.30(1)Page 154
Phone Number:1-301-816-8335