Penicillin G Sodium

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

C₁₆H₁₇N₂NaO₄S               356.37

4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, [2S-(2α,5α,6β)]-, monosodium salt; Monosodium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate   CAS RN®: 69-57-8; UNII: YS5LY7JF4N.

1 DEFINITION

Penicillin G Sodium has a potency of NLT 1500 and NMT 1750 Penicillin G Units/mg.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

B. Identification Tests—General 〈191〉, Sodium: Meets the requirements

3 ASSAY

Procedure

Solution A: 0.01 M monobasic potassium phosphate

Mobile phase: Methanol and Solution A (40:60)

System suitability solution: 0.1 mg/mL each of USP Penicillin G Potassium RS and 2-phenylacetamide in water Standard solution: 0.1 mg/mL of USP Penicillin G Potassium RS in water. Shake as needed to dissolve. This solution contains about 160 Penicillin G Units/mL.

Sample solution: 0.1 mg/mL of Penicillin G Sodium in water

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm × 10-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 10 µL

3.2 System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for 2-phenylacetamide and penicillin G are about 0.8 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between 2-phenylacetamide and penicillin G, System suitability solution

Column efficiency: NLT 1000 theoretical plates, Standard solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the potency of penicillin G sodium, in Penicillin G Units/mg, in the portion of Penicillin G Sodium taken:

Result = (r_U /r_S) × (C /C_U ) × P

r_U = peak response of penicillin G from the Sample solution

r_S = peak response of penicillin G from the Standard solution

C_S = concentration of USP Penicillin G Potassium RS in the Standard solution (mg/mL)

C_U = concentration of Penicillin G Sodium in the Sample solution (mg/mL)

P = potency of penicillin G in USP Penicillin G Potassium RS (Penicillin G Units/mg)

Acceptance criteria: 1500–1750 Penicillin G Units/mg

4 SPECIFIC TESTS

Crystallinity 〈695〉: Meets the requirements

pH 〈791〉

Sample solution: 60 mg/mL of Penicillin G Sodium in water

Acceptance criteria: 5.0–7.5

Loss on Drying 〈731〉

Sample: 100 mg of Penicillin G Sodium

Analysis: Dry the Sample in a capillary-stoppered bottle under a vacuum at a pressure NMT 5 mm of mercury at 60° for 3 h. Acceptance criteria: NMT 1.5%

Sterility Tests 〈71〉: Where the label states that Penicillin G Sodium is sterile, it meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.

Bacterial Endotoxins Test 〈85〉: Where the label states that Penicillin G Sodium is sterile or it must be subjected to further processing during the preparation of injectable dosage forms, it contains NMT 0.01 USP Endotoxin Units/100 Penicillin G Units.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

Labeling: Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.

USP Reference Standards 〈11〉

USP Penicillin G Potassium RS

USP Penicillin G Sodium RS