Cyclizine Hydrochloride Tablets

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

Cyclizine Hydrochloride Tablets contain NLT 93.0% and NMT 107.0% of the labeled amount of cyclizine hydrochloride (C₁₈H₂₂N₂ . HCI).

2 IDENTIFICATION

Change to read:

2.1 A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K (CN 1-MAY-2020)

Sample: Extract a quantity of powdered Tablets containing 100 mg of cyclizine hydrochloride with 10 mL of Ethanol. Filter, evaporate to dryness, and use the dried residue.

Acceptance criteria: Meet the requirements

3 ASSAY

3.1 PROCEDURE

Analysis: Proceed with Tablets as directed in Salts of Organic Nitrogenous Bases (501). Dilute the Standard Preparation and the Assay Preparation, respectively, with an equal volume of dilute sulfuric acid (1 in 100), and determine the absorbance at the wavelength of maximum absorbance at about 264 nm.

Calculate the percentage of the labeled amount of cyclizine hydrochloride (C₁₈H₂₂N₂ . HCI) in the portion of Tablets taken:

Result = (A_u/A_s) × (C_s/C_u) × 100

A_u = absorbance of the Assay Preparation

A_s = absorbance of the Standard Preparation

C_s = concentration of USP Cyclizine Hydrochloride RS in the Standard Preparation (mg/mL)

C_u = nominal concentration of cyclizine hydrochloride in the Assay Preparation (mg/mL)

Acceptance criteria: 93.0%-107.0%

4 PERFORMANCE TESTS

4.1 DISSOLUTION, Procedure for a Pooled Sample (711)

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 45 min

Analysis: Determine the amount of cyclizine hydrochloride (C₂H₂N, HCI) dissolved by proceeding as directed in the Assay, making any necessary modifications.

Tolerances: NLT 75% (Q) of the labeled amount of cyclizine hydrochloride (CH2N2 HCl) is dissolved.

4.2 UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements

5 IMPURITIES

5.1 ORGANIC IMPURITIES

Diluent: Methanol

Standard solution 1: 0.05 mg/mL of USP Cyclizine Hydrochloride RS in Diluent

Standard solution 2: 0.05 mg/mL of USP Cyclizine Related Compound A RS in Diluent

System

suitability solution: 1 mg/mL of USP Cyclizine Hydrochloride RS and 1 mg/mL of USP Hydroxyzine Hydrochloride RS in Diluent

Sample solution: Triturate a quantity of powdered Tablets containing 100 mg of cyclizine hydrochloride with 10 mL of methanol, and filter.

Chromatographic system

(See Chromatography (621), Thin-Layer Chromatography.)

Mode: TLC

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture

Application volume: 20 µL

Developing solvent system: Mix methylene chloride, methanol, and ammonium hydroxide (90:8:2). Allow the layers to separate, and use the

lower layer.

System suitability

Sample: System suitability solution

Suitability requirements

Resolution: The chromatogram shows two clearly visible and separated spots.

Analysis

Samples: Standard solution 1, Standard solution 2, and Sample solution

Proceed as directed in Chromatography (621), Thin-Layer Chromatography. Air-dry the plate for several min, expose it to iodine vapor for 20 min, and examine the plate under short-wavelength UV light.

Acceptance criteria

Cyclizine related compound A: The spot corresponding to cyclizine related compound A in the Sample solution is not more intense than the principal spot obtained from Standard solution 2 (NMT 0.5%).

Any unspecified impurity: Any other secondary spot in the chromatogram from the Sample solution is not more intense than the principal spot obtained from Standard solution 1 (NMT 0.5%).

6 ADDITIONAL REQUIREMENTS

6.1 PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.

6.2 USP REFERENCE STANDARDS (11)

USP Cyclizine Hydrochloride RS

USP Cyclizine Related Compound A RS

1-Methylpiperazine.

C₅H₁₂N₂       100.16

USP Hydroxyzine Hydrochloride RS