Bacteriostatic Sodium Chloride 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

Bacteriostatic Sodium Chloride Injection is a sterile, isotonic solution of Sodium Chloride in Water for Injection, and it contains one or more suitable antimicrobial agents. It contains NLT 0.85% and NMT 0.95% of NaCl.

[Note—Use Bacteriostatic Sodium Chloride Injection with due regard for the compatibility of the antimicrobial agent or agents it contains with the particular medicinal substance that is to be dissolved or diluted.]

2 IDENTIFICATION

Identification Tests—General, Sodium 〈191〉 and Chloride 〈191〉: Meets the requirements

3 ASSAY

Procedure

Sample solution: Equivalent to 90 mg of sodium chloride from the volume of Injection. Add water, if necessary, to bring the volume to 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS.

Analysis: Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of NaCl.

Acceptance criteria: 0.85%–0.95%

4 IMPURITIES

Change to read:

Inorganic Impurities

Iron 〈241〉, Procedures, Procedure 1

Test preparation: Dilute 5.0 mL of Injection with water to 45 mL, and add 2 mL of hydrochloric acid.

Acceptance criteria: NMT 2 ppm

5 SPECIFIC TESTS

Antimicrobial Agent(s): It meets the requirements under Antimicrobial Effectiveness Testing 〈51〉, and meets the labeled claim for content of the antimicrobial agent(s) as determined by the method set forth under Antimicrobial Agents—Content 〈341〉, except use the following procedure when methylparaben and Propylparaben are used as the antimicrobial agents.

Mobile phase: Methanol and water (7:3)

Standard stock solution: 1.2 mg/mL of USP Methylparaben RS and 0.12 mg/mL of USP Propylparaben RS in methanol

Standard solution: Pipet 5 mL of the Standard stock solution into a 50-mL volumetric flask, add by pipet 30 mL of methanol, and dilute with water to volume.

Sample solution: Pipet 1 mL of Injection into a 10-mL volumetric flask, add by pipet 7.0 mL of methanol, and dilute with water to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 30-cm; packing L1

Flow rate: 1.5 mL/min

Injection size: 12 µL

System suitability

Sample: Standard solution

Suitability requirements

Capacity factor: 0.52 for methylparaben and 1.05 for propylparaben

Resolution: NLT 2.0 between the methylparaben and propylparaben peaks

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration, in mg/mL, of methylparaben or propylparaben in the portion of Injection taken:

Result = (rᵤ/rₛ) × C

rᵤ = peak height from the Sample solution

rₛ = peak height from the Standard solution

C = concentration of USP Methylparaben RS or USP Propylparaben RS in the Standard solution (mg/mL)

Particulate Matter in Injections 〈788〉: Meets the requirements for small-volume injections

pH 〈791〉: 4.5–7.0

Bacterial Endotoxins Test 〈85〉: NMT 1.0 USP Endotoxin Unit/mL

Other Requirements: It meets the requirements under Injections and Implanted Drug Products 〈1〉.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, of not larger than 30-mL size, preferably of Type I or Type II glass.

Labeling: Label it to indicate the name(s) and proportion(s) of the added antimicrobial agent(s). Label it also to include the statement: NOT FOR USE IN NEWBORNS, in boldface capital letters, on the label immediately under the official name, printed in a contrasting color, preferably red. Alternatively, the statement may be placed prominently elsewhere on the label if the statement is enclosed within a box. Label it also to include the statement: NOT FOR INHALATION.

USP Reference Standards 〈11〉

USP Methylparaben RS

USP Propylparaben RS