Cefaclor Extended-Release Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Cefaclor Extended-Release Tablets contain the equivalent of NLT 90.0% and NMT 110.0% of the labeled amount of cefaclor ((C₁₅H₁₄CIN₃O₄S).).

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Mobile phase: Dissolve 1 g of sodium 1-pentanesulfonate in a mixture of 780 mL of water and 10 mL of triethylamine. Adjust with phosphoric acid to a pH of 2.5 ± 0.1, and add 220 mL of methanol.

System suitability solution: 0.3 mg/mL of USP Cefaclor RS and 0.3 mg/mL of USP Cefaclor Delta-3 Isomer RS in Mobile phase

Standard solution: 0.3 mg/mL of USP Cefaclor RS in Mobile phase. Sonicate briefly, if necessary, to achieve dissolution, and avoid heating the solution. Use within 8 h if stored at room temperature, or within 20 h if stored at 5°.

Sample solution: Transfer a quantity of finely powdered Tablets (NLT 20), nominally equivalent to 75 mg of cefaclor, to a 250-mL volumetric flask, and dilute with Mobile phase to volume. Sonicate, if necessary, to dissolve. Filter to obtain a clear solution.

3.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 265 nm. For Identification B, use a diode array detector in the range of 200–400 nm.

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

Flow rate: 1.5 mL/min

Injection volume: 20 μL

3.3 System suitability

Sample: System suitability solution

[Note—The relative retention times for cefaclor and cefaclor delta-3 isomer are about 1.0 and 1.35, respectively.]

3.4 Suitability requirements

Resolution: NLT 2.5 between the cefaclor peak and the cefaclor delta-3 isomer peak

Tailing factor: NMT 1.5 for the cefaclor peak

Relative standard deviation: NMT 1.0% for the cefaclor peak

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cefaclor ((C₁₅H₁₄CIN₃O₄S).) in the portion of Tablets taken:

Result = (r_U/r_S) x (C_S/C_U ) × P × F × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

C_U = nominal concentration of cefaclor in the Sample solution (mg/mL)

P = designated potency of USP Cefaclor RS (μg/mg)

F = conversion factor, 0.001 mg/μg

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1 (10-mesh basket): 100 rpm

Time: 30, 60, and 240 min

Standard solution: 0.025 mg/mL of USP Cefaclor RS in Medium

Sample solution: Filtered portion of the solution under test, diluted with Medium to obtain a solution with an estimated concentration of 25 μg/mL of cefaclor

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV

Analytical wavelength: Maximum absorbance at about 265 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cefaclor (C₁₅H₁₄CIN₃O₄S).) dissolved:

Result = (A_U/A_S) x C_S × V × (1/L) × 100

A_U = absorbance of the Sample solution

A_S = absorbance of the Standard solution

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

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: The percentages of the labeled amount of cefaclor (C₁₅H₁₄CIN₃O₄S) dissolved at the times specified conform to Table 1.

Table 1

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Organic Impurities

Diluent: 2.4 g/L of monobasic sodium phosphate in water, adjusted with phosphoric acid to a pH of 2.5

Solution A: 6.9 g/L of monobasic sodium phosphate in water, adjusted with phosphoric acid to a pH of 4.0

Solution B: Acetonitrile and Solution A (45:55), degassing for NMT 2 min

Mobile phase: See Table 2.

Table 2

Standard solution: 0.05 mg/mL of USP Cefaclor RS in Diluent. Sonicate briefly, if necessary, to dissolve, and avoid heating. Use within 18 h if stored at room temperature, or within 24 h when stored at 5°.

System suitability solution: 0.05 mg/mL of USP Cefaclor RS and 0.05 mg/mL of USP Cefaclor Delta-3 Isomer RS in Diluent

Sample solution: Nominally 5 mg/mL of cefaclor from Tablets prepared as follows. Weigh and finely powder NLT 20 Tablets. Transfer a portion of the powder, containing nominally about 50 mg of cefaclor, to a 10-mL volumetric flask. Dissolve in Diluent, using brief sonication, if necessary, to achieve dissolution. Avoid heating. Dilute with Diluent to volume, mix, and filter. Use within 3 h if stored at room temperature, or within 20 h if stored at 5°.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 220 nm

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

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Sample: System suitability solution

[Note—The relative retention times for cefaclor and cefaclor delta-3 isomer are 1.0 and 0.85, respectively.]

Suitability requirements

Resolution: NLT 2.0 between cefaclor delta-3 isomer and cefaclor

Tailing factor: NMT 1.2 for the cefaclor peak

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each related compound in the portion of Tablets taken:

Result = (r_U/r_S) x (C_S/C_U ) × P × F × 100

r_U = peak response of an individual related compound from the Sample solution

r_S = peak response of the cefaclor from the Standard solution

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

C_U = nominal concentration of cefaclor in the Sample solution (mg/mL)

P = potency of USP Cefaclor RS (μg/mg)

F = conversion factor, 0.001 mg/μg

Acceptance criteria

Individual impurities: NMT 0.6% of any individual cefaclor related compound

Total impurities: NMT 2.0% of all cefaclor related compounds. Disregard any peak less than 0.1%.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers, and store at controlled room temperature.

USP Reference Standards 〈11〉

USP Cefaclor RS

USP Cefaclor Delta-3 Isomer RS

(6R,7R)-7-{[(2R)-Aminophenylacetyl)]amino}-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic acid.

C₁₅H₁₄CIN₃O₄S 367.80