Carteolol Hydrochloride

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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C₁₆H₂₄N₂O₃· HCl 328.83

2(1H)-Quinolinone, 5-[3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]-3,4-dihydro-, monohydrochloride;

5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydrocarbo styril monohydrochloride CAS RN®: 51781-21-6; UNII: 4797W6I0T4.

1 DEFINITION

Carteolol Hydrochloride contains NLT 98.0% and NMT 101.5% of carteolol hydrochloride (C₁₆H₂₄N₂O₃· HCl), calculated on the dried basis.

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K or 197A (USP 1-May-2023)

Delete the following:

B. Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy (USP 1-May-2023)

Add the following:

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

May-2023)

Change to read:

C. Identification Tests—General 〈191〉 Chemical Identification Tests, Chloride (USP 1-May-2023)

Sample solution: 20 mg/mL

Acceptance criteria: Meets the requirements

3 ASSAY

Change to read:

Procedure

Solution A: 2.82 g/L of sodium 1-hexanesulfonate in water

Mobile phase: Acetonitrile, methanol, and Solution A (20:1:79)

Standard solution: 0.1 mg/mL of USP Carteolol Hydrochloride RS in Mobile phase

Sample solution: 0.1 mg/mL of Carteolol Hydrochloride in Mobile phase

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 252 nm

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

Flow rate: 1 mL/min

Injection volume: 20 μL

Run time: NLT 3.3 times the retention time of carteolol

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 0.5% (USP 1-May-2023)

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of carteolol hydrochloride (C₁₆H₂₄N₂O₃· HCl) in the portion of Carteolol Hydrochloride taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of carteolol from the Sample solution

r_S = peak response of carteolol from the Standard solution

C_S = concentration of USP Carteolol Hydrochloride RS in the Standard solution (mg/mL)

C_U = concentration of Carteolol Hydrochloride in the Sample solution (mg/mL)

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

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.1%

Delete the following:

Arsenic 〈211〉, Procedures, Method II (USP 1-May-2023)

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Organic Impurities

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

System suitability solution: 2 mg/mL of USP Carteolol Hydrochloride RS, 0.002 mg/mL of USP Carteolol Related Compound F RS, and 0.004 mg/mL of USP Dehydrocarteolol Hydrochloride RS in Mobile phase

Sensitivity solution: 0.001 mg/mL of USP Carteolol Hydrochloride RS in Mobile phase

Standard solution: 0.002 mg/mL of USP Carteolol Hydrochloride RS and 0.004 mg/mL of USP Dehydrocarteolol Hydrochloride RS in Mobile phase

Sample solution: 2 mg/mL of Carteolol Hydrochloride in Mobile phase

System suitability

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

[Note—The relative retention times for carteolol related compound F, dehydrocarteolol, and carteolol are about 0.77, 0.83, and 1.0, respectively.]

Suitability requirements

Resolution: NLT 1.5 between carteolol related compound F and dehydrocarteolol; NLT 2.0 between dehydrocarteolol and carteolol, System suitability solution

Tailing factor: NMT 2.0, Standard solution

Relative standard deviation: NMT 5.0% for carteolol and dehydrocarteolol, Standard solution

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

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of dehydrocarteolol hydrochloride in the portion of Carteolol Hydrochloride taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of dehydrocarteolol from the Sample solution

r_S = peak response of dehydrocarteolol from the Standard solution

C_S = concentration of USP Dehydrocarteolol Hydrochloride RS in the Standard solution (mg/mL)

C_U = concentration of Carteolol Hydrochloride in the Sample solution (mg/mL)

Calculate the percentage of any unspecified impurity in the portion of Carteolol Hydrochloride taken:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of any unspecified impurity from the Sample solution

r_S = peak response of carteolol from the Standard solution

C_S = concentration of USP Carteolol Hydrochloride RS in the Standard solution (mg/mL)

C_U = concentration of Carteolol Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: See Table 1. The reporting threshold is 0.05%.

Table 1

5 SPECIFIC TESTS

pH 〈791〉

Sample solution: 10 mg/mL

Acceptance criteria: 5.0–6.0

Loss on Drying 〈731〉

Analysis: Dry at 105° for 3 h.

Acceptance criteria: NMT 0.5%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Change to read:

USP Reference Standards 〈11〉

USP Carteolol Hydrochloride RS

USP Carteolol Related Compound F RS

5-(2-Hydroxy-3-methoxypropoxy)-3,4-dihydroquinolin-2(1H)-one.

C₁₃H₁₇NO₄· HCl 251.28

USP Dehydrocarteolol Hydrochloride RS

5-[3-(tert-Butylamino)-2-hydroxypropoxy]quinolin-2(1H)-one hydrochloride.

C₁₆H₂₂N₂O₃· HCl 326.82 (USP 1-May-2023)