Papaverine Hydrochloride Injection
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Papaverine Hydrochloride Injection is a sterile solution of Papaverine 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 C20H21NO4 · HCl.
Packaging and storage—Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
USP Reference standards 〈11〉—
USP Papaverine Hydrochloride RS
Identification—
A: Add 2 mL of alcohol to 1 mL of Injection, and evaporate on a steam bath, with the aid of a stream of nitrogen, to dryness. Dry the residue at 105° for 2 hours: it responds to Identification test A under Papaverine Hydrochloride.
B: It responds to Identification test C under Papaverine Hydrochloride.
Bacterial Endotoxins Test 〈85〉 —It contains not more than 2.9 USP Endotoxin Units per mg of papaverine hydrochloride.
pH 〈791〉: not less than 3.0.
Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.
Assay—Transfer 1.0 mL of Injection to a 200-mL volumetric flask, and dilute with water to volume. Pipet 3 mL of this solution into a separator, add 10 mL of water, and render alkaline with 6 N ammonium hydroxide. Extract the alkaloid with successive 5-mL portions of chloroform, and evaporate the extracts to dryness. Dissolve the residue in 0.1 N hydrochloric acid, and dilute with the same medium to 100.0 mL. Concomitantly determine the absorbances of this solution and of a Standard solution of USP Papaverine Hydrochloride RS in 0.1 N hydrochloric acid having a known concentration of about 4.5 µg per mL in 1-cm cells at the wavelength of maximum absorbance at about 251 nm, with a suitable spectrophotometer, using 0.1 N hydrochloric acid as the blank. Calculate the quantity, in mg, of C20H21NO4 · HCl in the portion of Injection taken by the formula:
6.67C(AU /AS )
in which C is the concentration, in µg per mL, of USP Papaverine Hydrochloride RS in the Standard solution, and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
