Procainamide 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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Procainamide Hydrochloride Injection

» Procainamide Hydrochloride Injection is a sterile solution of Procainamide Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C₁₃H₂₁N₃O·HCl.

Packaging and storage—

Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.

1 Labeling—

Label it to indicate that the Injection is not to be used if it is darker than slightly yellow, or is discolored in any other way.

USP Reference standards 〈11〉—

USP Procainamide Hydrochloride RS

2 Identification—

It responds to the Thin-Layer Chromatographic Identification Test 〈201〉, 5 µL of the clear supernatant being used to prepare the Assay preparation in the Assay and 5 µL of the stock solution being used to prepare the Standard preparation in the Assay being applied to the plate, and a solvent system consisting of a mixture of ethyl acetate, methanol, and ammonium hydroxide (22:2:1) being used to develop the chromatogram.

Bacterial Endotoxins Test 〈85〉—

It contains not more than 0.35 USP Endotoxin Unit per mg of procainamide hydrochloride.

pH 〈791〉—

between 4.0 and 6.0.

Particulate Matter in Injections 〈788〉—

meets the requirements under Small-volume injections.

Other requirements—

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

3 Assay—

Mobile phase, Standard preparation, Resolution solution, and Chromatographic system—Prepare as directed in the Assay under Procainamide Hydrochloride.

Assay preparation—

Transfer an accurately measured volume of Injection, equivalent to about 500 mg of procainamide hydrochloride, to a 500-mL volumetric flask, dilute with methanol to volume, and mix. Transfer 5.0 mL of this stock solution to a 100-mL volumetric flask, reserving the remainder of the stock solution for the Identification test. Dilute with Mobile phase to volume, and mix.

Procedure—

Proceed as directed for Procedure in the Assay under Procainamide Hydrochloride. Calculate the quantity, in mg, of C₁₃H₂₁N₃O·HCl in each mL of the Injection taken by the formula:

10,000(C/V)(rᵤ / rₛ)

in which

C is the concentration, in mg per mL, of USP Procainamide Hydrochloride RS in the Standard preparation,

V is the volume, in mL, of Injection taken, and

rᵤ and rₛ are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.