Cefaclor for Oral Suspension

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 for Oral Suspension is a dry mixture of Cefaclor and one or more suitable buffers, colors, diluents, and flavors. It contains the equivalent of NLT 90.0% and NMT 120.0% 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

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 stock solution: Constitute Cefaclor for Oral Suspension as directed in the labeling, freshly mixed and free from air bubbles.

Sample solution: Nominally 0.3 mg/mL of cefaclor from Sample stock solution diluted with Mobile phase. Sonicate if necessary to ensure complete dissolution of the cefaclor, and filter to obtain a clear solution.

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 x 25-cm; 5-µm packing L1

Flow rate: 1.5 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 about 1.0 and 1.35, respectively.]

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

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cefaclor (C₁₅H₁₄CIN₃O₄S) in the portion of Cefaclor for Oral Suspension taken:

Result = (r_U/r_S) x (C_S/C_U) xPxFx100

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

DELIVERABLE VOLUME (698): Meets the requirements

UNIFORMITY OF DOSAGE UNITS (905): For solid packaged in single-unit containers, meets 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 1

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 stock solution: Constitute Cefaclor for Oral Suspension as directed in the labeling, freshly mixed and free from air bubbles.

Sample solution: Nominally 5 mg/mL of cefaclor from Sample stock solution diluted with Diluent. Sonicate if necessary, avoid heating to ensure complete dissolution of the cefaclor, and filter. Use within 3 h if stored at room temperature, or within 20 h when stored at 5^o. 

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm x 25-cm; 5-um packing 11

Flow rate: 1 mL/min

Injection volume: 20 µl

System suitability

Suitability requirements

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 Cefaclor for Oral Suspension taken:

Result = (r_U/r_S) x (C_S/C_U) xPxFx100

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 cefaclor in USP Cefaclor RS (µg/mg)

F = conversion factor, 0.001 mg/µg

Acceptance criteria

Individual impurities: NMT 1.0% of any individual cefaclor related compound

Total impurities: NMT 3.0% of all cefaclor related compounds. Disregard any peak less than 0.1%.

6 SPECIFIC TESTS

pH 〈791〉

Sample: Suspension constituted as directed in the labeling

Acceptance criteria: 2.5–5.0

7 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.

C₁₅H₁₄CIN₃O₄S 367.80