Prochlorperazine

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 contains NLT 98.0% and NMT 101.0% 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

Sample: 400 mg of Prochlorperazine

Analysis: Transfer the Sample to a 125-mL conical flask. Add 30 mL of glacial acetic acid, and warm on a steam bath to dissolve. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination (see Titrimetry 〈541〉), and make any necessary corrections. Each mL of 0.1 N perchloric acid is equivalent to 18.70 mg of prochlorperazine (C₂₀H₂₄ClN₃S).

Acceptance criteria: 98.0%–101.0%

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Ordinary Impurities 〈466〉

Standard solution: Methanol

Sample solution: Methanol

Eluant: Methanol and ammonium hydroxide (100:1)

Visualization: 1

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Prochlorperazine Maleate RS