Tetracaine Hydrochloride in Dextrose 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

Tetracaine Hydrochloride in Dextrose Injection is a sterile solution of Tetracaine Hydrochloride and Dextrose in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amounts of tetracaine hydrochloride and dextrose.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020)

B. Identification Tests—General 〈191〉, Chloride

Sample solution: 100 mg in 5 mL of water

Acceptance criteria: Meets the requirements

C.

Sample solution: Nominally 50 mg/mL of dextrose from Injection

Analysis: Add a few drops of the Sample solution to 5 mL of hot alkaline cupric tartrate TS.

Acceptance criteria: A copious red precipitate of cuprous oxide is formed.

3 ASSAY

Tetracaine Hydrochloride

Buffer: Buffer B.6 (see Antibiotics—Microbial Assays 〈81〉, Media and Solutions, Solutions, Buffers,Table 12)

Diluent: Dilute hydrochloric acid (1 in 200)

Standard stock solution: 0.2 mg/mL of USP Tetracaine Hydrochloride RS in water

Standard solution: 0.01 mg/mL of USP Tetracaine Hydrochloride RS prepared as follows. Pipet 5 mL of the Standard stock solution into a 100-mL volumetric flask, add 5 mL of Diluent and 10 mL of Buffer, and dilute with water to volume.

Sample stock solution: Nominally 0.2 mg/mL of tetracaine hydrochloride from Injection prepared as follows. Transfer a volume of Injection, equivalent to 10 mg of tetracaine hydrochloride, to a separator. Dilute with water to about 50 mL, and render alkaline by the addition of 5 mL of sodium carbonate TS. Extract immediately with two 50-mL portions of ether, collecting the extracts in a separator. Wash the ether extracts with 20 mL of water, discarding the wash solution, and extract the ether solution with two 20-mL portions and one 5-mL portion of

Diluent, collecting the extracts in a 50-mL volumetric flask. Dilute with water to volume.

Sample solution: Nominally 0.01 mg/mL of tetracaine hydrochloride from Sample stock solution prepared as follows. Transfer 5.0 mL of the

Sample stock solution to a 100-mL volumetric flask, add 10 mL of Buffer, and dilute to volume with water.

Instrumental conditions

Mode: UV

Analytical wavelength: Maximum absorbance at about 310 nm

Blank: Water

Analysis

Samples: Standard solution, Sample solution, and Blank

Calculate the percentage of labeled amount of tetracaine hydrochloride in the portion of Injection taken:

Result = (A_U/A_S) × (C_S/C_U) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

C_S = concentration of USP Tetracaine Hydrochloride RS in the Standard solution (mg/mL)

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

Acceptance criteria: 95.0%–105.0%

Dextrose

Sample: Injection

Analysis: Determine the angular rotation of the Injection in a suitable polarimeter tube (see Optical Rotation 〈781〉).

Calculate the percentage of the labeled amount of dextrose in the portion of Injection taken:

Result = [(100 × a)/(l × α)] × (1/C_U) × 100

a = observed angular rotation of the Injection (°)

l = length of the polarimeter tube (dm)

α = midpoint of the speci

c rotation range for anhydrous dextrose, 52.9°

C_U = nominal concentration of dextrose in the Sample (g/100 mL)

Acceptance criteria: 95.0%–105.0%

4 SPECIFIC TESTS

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

Bacterial Endotoxins Test 〈85〉: It contains NMT 1.0 USP Endotoxin Unit/mg of tetracaine hydrochloride.

pH 〈791〉: 3.5–6.0

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

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass, under refrigeration and protected from light. It may be packaged in 100-mL multiple-dose containers. Injection supplied as a component of spinal anesthesia trays may be stored at room temperature for 12 months.

Labeling: Label it to indicate that the Injection is not to be used if it contains crystals, or if it is cloudy or discolored.

USP Reference Standards 〈11〉

USP Tetracaine Hydrochloride RS