Cefaclor Capsules

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

Cefaclor Capsules contain NLT 90.0% and NMT 120.0% of the labeled amount of cefaclor (C₁₅H₁₄ClN₃O₄S).

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: Nominally 0.3 mg/mL of cefaclor prepared as follows. Remove the contents of NLT 20 Capsules as completely as possible, and weigh. Mix the combined contents, and transfer a portion of the powder, 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 and cefaclor delta-3 isomer peaks

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 (C₁₅H₁₄ClN₃O₄S) in the portion of Capsules 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%–120.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard solution: A known concentration of USP Cefaclor RS in Medium

Sample solution: Filtered portion of the solution under test, suitably diluted with Medium, if necessary Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV

Analytical wavelength: Maximum absorbance at about 264 nm

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cefaclor (C₁₅H₁₄ClN₃O₄S) dissolved:

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

A = absorbance of the Sample solution

A = absorbance of the Standard solution

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

Tolerances: NLT 80% (Q) of the labeled amount of cefaclor (C₁₅H₁₄ClN₃O₄S) is dissolved.

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 adjusted with phosphoric acid to a pH of 4.0

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

Mobile phase: See Table 1.

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 Capsules prepared as follows. Remove the contents of NLT 20 Capsules as

completely as possible, and mix. Transfer a portion of the combined contents, 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 when 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 delta-3 isomer and cefaclor are about 0.85 and 1.0, 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 Capsules 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 peak 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: The reporting level for impurities is 0.1%.

Individual impurities: NMT 0.5% of any individual cefaclor-related compound

Total impurities: NMT 2.0% of all cefaclor-related compounds

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

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.

C₁₅H₁₄ClN₃O₄S 367.80