Sodium Chloride Compounded Injection

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

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

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1 DEFINITION

Sodium Chloride Compounded Injection 234 mg/mL, 23.4%, (4 mEq/mL) contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl).

Prepare Sodium Chloride Compounded Injection 234 mg/mL, 23.4%, (4 mEq/mL) as follows (see Pharmaceutical Compounding—Sterile Preparations 〈797〉).

In a suitable calibrated container, dissolve the Sodium chloride in about 27 mL of Sterile water for Injection. Add sufficient Sterile water for

Injection to bring to final volume, and mix well. Pass through a sterile filter of 0.22-μm pore size into sterile single-dose container(s).

2 ASSAY

Procedure

Mobile phase: 0.52 mL/L of methanesulfonic acid in water

Standard solution: 25 μg/mL of USP Sodium Chloride RS in water. Vortex or shake until well mixed.

Sample solution: Transfer about 2 mL of injection into a polystyrene cup. Pipette a 1.0 mL sample with a micropipette into a 100-mL volumetric flask. Rinse the pipette tip 2 times using water and add contents into the flask. Bring to volume with water. Vortex or shake until well mixed. Transfer 0.7 mL of the solution into a 25-mL volumetric flask. Rinse the pipette tip 2 times and add contents into the volumetric flask. Bring to volume with water. Vortex or shake until well mixed.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: Conductivity

Column: 4-mm × 25-cm; packing L77

Column temperature: 30°

Flow rate: 1.0 mL/min

Injection volume: 10 μL

System suitability

Sample: Standard solution

[Note—The retention time for sodium chloride is about 3.21 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sodium chloride (NaCl) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S /C_U ) × 100

r_U = peak response of sodium chloride from the Sample solution

r_S = peak response of sodium chloride from the Standard solution

C_S = concentration of USP Sodium Chloride RS in the Standard solution (μg/mL)

C_U = nominal concentration of sodium chloride in the Sample solution (μg/mL)

Acceptance criteria: 95.0%–105.0%

3 SPECIFIC TESTS

pH 〈791〉: 4.5–7.0

Sterility Tests 〈71〉: It meets the requirements when tested as directed in the Test for Sterility of the Product to Be Examined, Membrane

Filtration.

Bacterial Endotoxins Test 〈85〉: NMT 3.6 USP Endotoxin units/mL

Particulate Matter in Injections 〈788〉: It meets the requirements.

Appearance: Clear, colorless solution with no particulates

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant glass sterile single-dose container(s). Store at controlled room temperature.

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature.

Labeling: Label to indicate that it is a concentrate, not for direct injection, and must be diluted prior to administration. Label to indicate that the osmolarity is 8.01 mOsm/mL (calc). Label to state single-use. Label to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Sodium Chloride RS (USP 1-Aug-2023)