Procaine Hydrochloride 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

Procaine Hydrochloride Injection is a sterile solution of Procaine Hydrochloride in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of procaine hydrochloride (C₁₃H₂₀N₂O₂·HCl).

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Evaporate a portion of Injection, equivalent to 20 mg of procaine hydrochloride, on a steam bath just to dryness, and dry over silica gel for 18 h. Use the residue for the test.

B.

Solution A: 100 mg/mL of sodium hydroxide in water

Solution B: 20 mg/mL of 2-naphthol in Solution A

Analysis: Dissolve 10 mg of the residue obtained in Identification A in 1 mL of water, add 1 drop each of hydrochloric acid and 100 mg/mL of sodium nitrite in water, then add 1 mL of Solution B, and shake.

Acceptance criteria: A scarlet-red precipitate is formed.

3 ASSAY

Procedure

Standard solution: Transfer to a 125-mL separator about 50 mg, accurately weighed, of USP Procaine Hydrochloride RS and dissolve in 20 mL of water.

Sample solution: Transfer to a 125-mL separator an accurately measured volume of Injection, equivalent to about 50 mg of procaine hydrochloride, and dilute with water to 20 mL.

Instrumental conditions

Mode: UV

Analytical wavelength: 280 nm

Blank: Chloroform

Analysis

Samples: Standard solution and Sample solution

Add 5 mL of ammonium hydroxide, 6 N, to both the Standard solution and Sample solution, then treat each as follows. Extract with five 25-mL portions of chloroform, and filter the combined extracts through 1 g of sodium sulfate, anhydrous supported on a pledget of glass wool. Receive the filtrate in a 200-mL volumetric flask, and add chloroform to volume. Transfer 3.0 mL of this solution to a 100-mL volumetric flask, and add chloroform to volume. Concomitantly determine the absorbances of both solutions.

Calculate the percentage of the labeled amount of procaine hydrochloride (C₁₃H₂₀N₂O₂·HCl) in the portion of Injection taken:

Result = (Aᵤ / Aₛ) × (Cₛ / Cᵤ) × 100

Aᵤ = absorbance of the Sample solution

Aₛ = absorbance of the Standard solution

Cₛ = concentration of USP Procaine Hydrochloride RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of procaine hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–105.0%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: It contains NMT 0.6 USP Endotoxin Units/mg of procaine hydrochloride.

pH 〈791〉: 3.0–5.5

Particulate Matter in Injections 〈788〉: It meets the requirements under small-volume injections.

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

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass. The Injection may be packaged in 100-mL multiple-dose containers.

USP Reference Standards 〈11〉

USP Procaine Hydrochloride RS