Lidocaine Hydrochloride and 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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Lidocaine Hydrochloride and Dextrose Injection is a sterile solution of Lidocaine Hydrochloride and Dextrose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amounts of lidocaine hydrochloride (C₁₄H₂₂N₂O · HCl) and dextrose (C₆H₁₂O₆ · H₂O).

1 Packaging and storage

Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass.

USP Reference standards 〈11〉—

USP Lidocaine RS

2 Identification

A: Place in a separator a volume of Injection equivalent to about 300 mg of lidocaine hydrochloride, add 2 mL of 2 N sodium hydroxide, and extract with four 15-mL portions of chloroform. Combine the chloroform extracts, and evaporate with the aid of a current of warm air to dryness. Dissolve the crystals so obtained in solvent hexane, evaporate with the aid of warm air, and dry the residue in vacuum over silica gel for 24 hours: the residue so obtained responds to Identification test A under Lidocaine.

B: Add a few drops of a solution (1 in 20) to 5 mL of hot alkaline cupric tartrate TS. A copious red precipitate of cuprous oxide is formed.

Bacterial Endotoxins Test 〈85〉—It contains not more than 1.1 USP Endotoxin Units per mg of lidocaine hydrochloride.

pH 〈791〉: between 3.0 and 7.0.

3 Other requirements

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

Change to read:

4 Assay for lidocaine hydrochloride

Proceed with Injection as directed in the Assay for lidocaine hydrochloride under Lidocaine Hydrochloride (ERR 1-Mar-2023) and Epinephrine Injection.

5 Assay for dextrose

Determine the angular rotation of Injection in a suitable polarimeter tube (see Optical Rotation 〈781〉). Calculate the percentage (g per 100 mL) of dextrose (C₆H₁₂O₆ · H₂O) in the portion of Injection taken by the formula:

(100/52.9)(198.17/180.16)AR

in which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.