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 4.0 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 contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of penicillin G. In addition, where it contains Sodium Citrate it has a potency of not less than 1420 and not more than 1667 Penicillin G Units per mg.
Packaging and storage—
Preserve in Containers for Sterile Solids as described under Injections 
1
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Constituted solution—
At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
1.
Identification—
It responds to the Identification test under Penicillin G Potassium for Injection.
Crystallinity 695:
meets the requirements.
695:
meets the requirements.
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.
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.
pH 791:
between 5.0 and 7.5, in a solution containing 60 mg per mL, except where it is labeled as containing sodium citrate it is between 6.0 and 7.5.
791:
between 5.0 and 7.5, in a solution containing 60 mg per mL, except where it is labeled as containing sodium citrate it is between 6.0 and 7.5.
Loss on drying 731—
Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury 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 a pressure not exceeding 5 mm of mercury 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 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 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 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 160 Penicillin G Units per mL.
Assay preparation 3 (where it contains Sodium Citrate)—
Transfer about 50 mg of the Penicillin G Sodium 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 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 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 Sodium 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 Sodium 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.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4251
Pharmacopeial Forum: Volume No. 30(1) Page 154