Prochlorperazine Edisylate 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

Prochlorperazine Edisylate Injection is a sterile solution of Prochlorperazine Edisylate in Water for Injection. It contains an amount of prochlorperazine edisylate equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of prochlorperazine (C₂₀H₂₄ClN₃S).

[Note—Throughout the following procedures, protect the sample, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.]

2 IDENTIFICATION

A. Identification—Organic Nitrogenous Bases 〈181〉: Meets the requirements when USP Prochlorperazine Maleate RS is used as the standard for comparison

3 ASSAY

Procedure

Buffer: 2.68 g/L of dibasic sodium phosphate heptahydrate in water, adjusted with phosphoric acid to a pH of 3.0

Mobile phase: Acetonitrile and Buffer (7:3)

Standard solution: Equivalent to 0.1 mg/mL of prochlorperazine, from USP Prochlorperazine Maleate RS in Mobile phase

Sample solution: Transfer a portion of Injection, equivalent to 10 mg of prochlorperazine, to a 100-mL volumetric flask, and dilute with Mobile phase to volume.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 3.9-mm × 30-cm; packing L1

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 3000 theoretical plates

Tailing factor: NMT 2.5

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of prochlorperazine (C₂₀H₂₄ClN₃S) in the portion of Injection taken:

Result = (r₁ / r₂) × (C₁ / C₂) × 100

r₁ = peak response from the Sample solution

r₂ = peak response from the Standard solution

C₁ = concentration of prochlorperazine in the Standard solution (mg/mL)

C₂ = nominal concentration of prochlorperazine in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

Bacterial Endotoxins Test 〈85〉: NMT 17.9 USP Endotoxin Units/mg of prochlorperazine

pH 〈791〉: 4.2–6.2

Other Requirements: It 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 glass, protected from light.

USP Reference Standards 〈11〉