Penicillin G Potassium for Injection
» Penicillin G Potassium for Injection is sterile Penicillin G Potassium or a sterile, dry mixture of Penicillin G Potassium with not less than 4.0 percent and not more than 5.0 percent of Sodium Citrate, of which not more than 0.15 percent may be replaced by Citric Acid. It has a potency of not less than 90.0 percent and not more than 120.0 percent of the labeled number of Penicillin G Units. In addition, where it contains Sodium Citrate it has a potency of not less than 1335 and not more than 1595 Penicillin G Units per mg.
Constituted solution—
At the time of use, it meets the requirements for Constituted Solutions under Injections 
1
.
1.
Identification—
Prepare a solution of it containing about 12,000 Penicillin G Units per mL in a solvent mixture consisting of acetone, 0.1 M citric acid, and 0.1 M sodium citrate (2:1:1). Prepare a Standard solution of USP Penicillin G Potassium RS containing about 12,000 Penicillin G Units per mL in the same solvent mixture. Apply separately 20 µL of each solution to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of toluene, dioxane, and glacial acetic acid (90:25:4) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, mark the solvent front, and allow to air-dry. Spray the plate with starch TS followed by dilute iodine TS (1 in 10). Penicillin G appears as a white spot on a purple background: the RF value of the penicillin G spot obtained from the test solution corresponds to that obtained from the Standard solution.
621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Place the plate in a suitable chromatographic chamber, and develop the chromatogram in a solvent system consisting of a mixture of toluene, dioxane, and glacial acetic acid (90:25:4) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, mark the solvent front, and allow to air-dry. Spray the plate with starch TS followed by dilute iodine TS (1 in 10). Penicillin G appears as a white spot on a purple background: the RF value of the penicillin G spot obtained from the test solution corresponds to that obtained from the Standard solution.
Crystallinity 695:
meets the requirements.
695:
meets the requirements.
Bacterial endotoxins 85—
It contains not more than 0.01 USP Endotoxin Unit per 100 Penicillin G Units.
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.
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 5.0 and 7.5, in a solution containing 60 mg per mL, or, where packaged for dispensing, in the solution constituted as directed in the labeling, except where it is labeled as containing sodium citrate it is between 6.0 and 8.5.
791:
between 5.0 and 7.5, in a solution containing 60 mg per mL, or, where packaged for dispensing, in the solution constituted as directed in the labeling, except where it is labeled as containing sodium citrate it is between 6.0 and 8.5.
Loss on drying 731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at 60
for 3 hours: it loses not more than 1.5% of its weight.
731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at 60 for 3 hours: it loses not more than 1.5% of its weight.
Particulate matter 788:
meets the requirements for small-volume injections.
788:
meets the requirements for small-volume injections.
Other requirements—
It meets the requirements for Uniformity of Dosage Units 905, and Labeling under Injections 1.
905, and Labeling under Injections 1.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—
Proceed as directed in the Assay under Penicillin G Potassium.
Assay preparation 1
(where it is represented as being in a single-dose container)—Constitute Penicillin G Potassium 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 160 Penicillin G Units per mL.
Assay preparation 2
(where the label states the quantity of penicillin G in a given volume of constituted solution)—Constitute Penicillin G Potassium 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 160 Penicillin G Units per mL.
Assay preparation 3
(where it contains Sodium Citrate)—Transfer about 50 mg of the Penicillin G Potassium for Injection, accurately weighed, to a 500-mL volumetric flask, add about 400 mL of water, and shake to dissolve. Dilute with water to volume, and mix.
Procedure—
Proceed as directed for Procedure in the Assay under Penicillin G Potassium. 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 L is the labeled quantity of Penicillin G Units in the container or in the volume of constituted solution taken; D is the concentration, in Penicillin G Units per mL, of Assay preparation 1 or 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; P is the specified potency, in Penicillin G Units per mg, of USP Penicillin G Potassium RS; WS is the weight, in mg, of USP Penicillin G Potassium RS taken to prepare the Standard preparation; and rU and rS are the penicillin G peak responses obtained from the Assay preparation and the Standard preparation, respectively. Calculate the potency, in Penicillin G Units per mg, of the Penicillin G Potassium for Injection taken by the formula:
10(WS / WU)(P)(rU / rS)
in which WS and WU are the weights, in mg, of USP Penicillin G Potassium RS and Penicillin G Potassium for Injection taken to prepare the Standard preparation and Assay preparation 3, respectively, and the other terms are as defined above. Perform the above procedure on 10 containers (where it is represented as being in a single-dose container) and, if necessary, on 10 containers (where the label states the quantity of penicillin G in a given volume of constituted solution). Use the individual results to determine the Uniformity of dosage units and the average thereof as the Assay value.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| 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 |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3229
Pharmacopeial Forum: Volume No. 30(1) Page 154
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.