Sodium Bicarbonate 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 Bicarbonate Compounded Injection contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium bicarbonate (NaHCO₃). It contains no bacteriostat or other preservatives.

Prepare Sodium Bicarbonate Compounded Injection 8.4% (1 mEq/mL) as follows (see Pharmaceutical Compounding—Sterile Preparations 〈 797〉).

Dissolve the Sodium Bicarbonate in sufficient Sterile Water for Injection and bring to final volume. Pass through a sterile filter of 0.22-µm pore size into a sterile container.

2 ASSAY

Change to read:

2.1 PROCEDURE FOR SODIUM

Mobile phase: 8 mM methanesulfonic acid

Standard solution: 0.025 mg/mL of sodium prepared with USP Sodium Chloride RS and water

Sample solution: Transfer 1 mL of Injection into a 100-mL volumetric flask, and dilute with water to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.) Mode: LC

Detector: Conductivity

Column: 4.0 (USP 1-May-2024) -mm × 25-cm; packing L97

Column temperature: 30°

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[NOTE—The retention time for sodium is about 3.6 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 (Na) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak response of sodium from the Sample solution

r_S = peak response of sodium from the Standard solution

C_S = concentration of sodium in the Standard solution (mg/mL)

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

Acceptance criteria: 95.0%–105.0%

2.2 PROCEDURE FOR SODIUM BICARBONATE

Sample solution: A volume of Injection, equivalent to about 3 g of sodium bicarbonate

Titrimetric system

(See Titrimetry 〈541〉.)

Mode: Direct titration

Titrant: 1 N hydrochloric acid VS Endpoint detection: Visual

Analysis: Add methyl red TS to the Sample solution. Add Titrant slowly, with constant stirring, until the solution becomes faintly pink. Heat the solution to boiling, cool, and continue the titration until the faint pink color no longer fades after boiling. Perform a blank determination, and make any necessary correction.

Calculate the percentage of the labeled amount of sodium bicarbonate (NaHCO ) in the portion of Injection taken:

Result = [(V_S − V_B) × N_A × F × 100]/W

V_S = Titrant volume consumed by the Sample solution (mL)

V_B = Titrant volume consumed by the blank (mL)

N_A = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 84.01 mg/mEq

W = sample weight (mg)

Acceptance criteria: 95.0%–105.0%

3 SPECIFIC TESTS

PH 〈791〉: 7.0–8.5

STERILITY TESTS 〈71〉: Meets the requirements

BACTERIAL ENDOTOXINS TEST 〈85〉: NMT 5.0 USP Endotoxin Units/mEq of sodium bicarbonate

PARTICULATE MATTER IN INJECTIONS 〈788〉: Meets the requirements for small-volume injections

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in single-dose glass containers. Store at controlled room temperature.

BEYOND-USE DATE: In the absence of passing a sterility and endotoxin test, the storage conditions for high-risk compounded sterile preparations (CSPs) in Pharmaceutical Compounding—Sterile Preparations 〈797〉 apply. After successful completion of sterility and endotoxin testing, NMT 120 days after the date on which it was compounded when stored at controlled room temperature.

LABELING: Label it to state the Beyond-Use Date. The label states the total osmolar concentration in mOsmol/mL.

USP REFERENCE STANDARDS 〈11〉

USP Sodium Chloride RS