Prochlorperazine Edisylate

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 contains NLT 98.0% and NMT 101.5% of prochlorperazine edisylate (C₂₀H₂₄ClN₃S · C₂H₆O₆S₂), calculated on the dried basis.

[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

B. Identification Tests—General, Sulfite 〈191〉

Sample: Fuse 100 mg with a few pellets of sodium hydroxide.

Acceptance criteria: The cooled melt meets the requirements.

3 ASSAY

Procedure

Sample solution: Transfer 750 mg of Prochlorperazine Edisylate to a separator containing 40 mL of water, and shake to dissolve.

Analysis: Render the Sample solution alkaline with ammonium hydroxide, and extract with three 25-mL portions of ether. Wash the combined ether extracts once with 25 mL of water, discard the washing, and evaporate the ether solution on a steam bath to dryness. Dissolve the residue in 60 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, using crystal violet TS as the indicator. Perform a blank determination (see Titrimetry 〈541〉), and make any necessary corrections. Each mL of 0.1 N perchloric acid is equivalent to 28.21 mg of prochlorperazine edisylate (C₂₀H₂₄ClN₃S · C₂H₆O₆S₂).

Acceptance criteria: 98.0%–101.5% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Change to read:

▲Selenium 〈291〉, Procedures, Procedure 1▲ (CN 1-Jun-2023)

Sample: 100 mg of Prochlorperazine Edisylate, mixed with 100 mg of magnesium oxide

Acceptance criteria: NMT 30 ppm

Ordinary Impurities 〈466〉

Standard solution: Methanol and ammonium hydroxide (9:1)

Sample solution: Methanol and ammonium hydroxide (9:1)

Eluant: Chloroform, toluene, alcohol, and ammonium hydroxide (50:50:50:0.5)

Spray reagent: Mix 2 mL of chloroplatinic acid solution (1 in 10) and 50 mL of potassium iodide solution (4 in 100). Dilute with water to 100mL, and acidify with 1 N hydrochloric acid.

Visualization: 1, followed by Spray reagent

5 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry a sample under vacuum at 100° for 3 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

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

USP Reference Standards 〈11〉