Xylometazoline Hydrochloride Nasal Solution

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

Xylometazoline Hydrochloride Nasal Solution is an isotonic solution of Xylometazoline Hydrochloride in water. It contains NLT 90.0% and NMT 110.0% of the labeled amount of xylometazoline hydrochloride (C₁₆H₂₄N₂ · HCl).

2 IDENTIFICATION

Change to read:

A. The UV spectrum of the xylometazoline peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay _{(USP 1-Aug-2019)}

Add the following:

B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay _{(USP 1-Aug-2019)}

3 ASSAY

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PROCEDURE

Solution A: 1.4 g/L of monobasic potassium phosphate. Adjust with phosphoric acid to a pH of 3.0.

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

System suitability solution: 0.01 mg/mL each of USP Xylometazoline Hydrochloride RS and USP Xylometazoline Related Compound A RS in water

Standard solution: 0.05 mg/mL of USP Xylometazoline Hydrochloride RS in water

Sample solution: Nominally 0.05 mg/mL of xylometazoline hydrochloride from a suitable volume of Nasal Solution in water

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm. For Identication A, use a diode array detector in the range of 210–300 nm.

Column: 4.6-mm × 25-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times are given in Table 2.]

Suitability requirements

Resolution: NLT 2.0 between xylometazoline related compound A and xylometazoline, System suitability solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 1.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of xylometazoline hydrochloride (C₁₆H₂₄N₂ · HCl) in the portion of Nasal Solution taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of xylometazoline from the Sample solution

r_s = peak response of xylometazoline from the Standard solution

C_s = concentration of USP Xylometazoline Hydrochloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of xylometazoline hydrochloride in the Sample solution (mg/mL) _{(USP 1-Aug-2019)}

Acceptance criteria: 90.0%–110.0%

4 IMPURITIES

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ORGANIC IMPURITIES

Solution A, Solution B, Mobile phase, System suitability solution, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.001 mg/mL of USP Xylometazoline Hydrochloride RS in water

Sensitivity solution: 0.5 µg/mL of USP Xylometazoline Hydrochloride RS from the Standard solution in water

Sample solution: Nominally 0.5 mg/mL of xylometazoline hydrochloride from a suitable volume of Nasal Solution in water

System suitability

Samples: System suitability solution, Standard solution, and Sensitivity solution

[NOTE-The relative retention times are given in Table 2.]

Suitability requirements

Resolution: NLT 2.0 between xylometazoline related compound A and xylometazoline, System suitability solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 5.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each degradation product in the portion of Nasal Solution taken:

Result = (r_u /r_s ) × (C_s /C_u ) × (1/F) × 100

r_u = peak response of each degradation product from the Sample solution

r_s = peak response of xylometazoline from the Standard solution

C_s = concentration of USP Xylometazoline Hydrochloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of xylometazoline hydrochloride in the Sample solution (mg/mL)

F = relative response factor for the corresponding degradation product (see Table 2)

Acceptance criteria: See Table 2. The reporting threshold is 0.10%.

Table 2

5 SPECIFIC TESTS

pH 〈791〉: 5.0–7.5

Add the following:

Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉: The total aerobic microbial count does not exceed 10² cfu/g,

and the total combined molds and yeasts count does not exceed 10¹ cfu/g. It meets the requirements of the tests for the absence of Staphylococcus aureus and Pseudomonas aeruginosa. _{(USP 1-Aug-2019)}

6 ADDITIONAL REQUIREMENTS

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Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature. _{(USP 1-Aug-2019)}

Change to read:

USP Reference Standards 〈11〉

USP Xylometazoline Hydrochloride RS

USP Xylometazoline Related Compound A RS

N-(2-Aminoethyl)-2-[4-(tert-butyl)-2,6-dimethylphenyl]acetamide.

C₁₆H₂₆N₂O          262.39 _{(USP 1-Aug-2019)}