Albendazole 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 

Albendazole Oral Suspension is Albendazole in an aqueous vehicle. It contains one or more preservatives and dispersing or suspending agents. It contains NLT 90.0% and NMT 110.0% of the labeled amount of albendazole (C₁₂H₁₅N₃O₂S). 

2 IDENTIFICATION 

Change to read: 

Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U_{(CN 1-May-2020)} 

Sample stock solution: 1 mg/mL of albendazole from a quantity of Suspension, in a mixture of methanol and hydrochloric acid (99:1). Filter the mixture, if necessary, to obtain a clear solution. 

Sample solution: 0.01 mg/mL of albendazole in 0.1 N sodium hydroxide from Sample stock solution 

Acceptance criteria: Meets the requirements 

3 ASSAY 

3.1 Procedure 

Solution A: Methanol and hydrochloric acid (99:1) 

Solution B: 13.75 g/L of monobasic sodium phosphate 

Mobile phase: Methanol and Solution B (60:40) 

Standard stock solution: 1 mg/mL of USP Albendazole RS in Solution A 

Standard solution: 100 µg/mL of USP Albendazole RS from Standard stock solution in Mobile phase 

Sample stock solution: Equivalent to 1 mg/mL of albendazole from a volume of Oral Suspension in Solution A Sample solution: Nominally 100 µg/mL of albendazole from Sample stock solution in Mobile phase. [Note—Filter, if necessary, to obtain a clear solution.] 

3.2 Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 308 nm 

Column: 4-mm × 25-cm; packing L1 

Flow rate: 2 mL/min 

Injection volume: 20 µL 

System suitability 

Sample: Standard solution 

Suitability requirements 

Column eciency: NLT 2000 theoretical plates 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 2.0% 

3.3 Analysis 

Samples: Standard solution and Sample solution 

Calculate the percentage of albendazole (C₁₂H₁₅N₃O₂S) in the portion of Oral Suspension taken: 

Result = (r_U /r_S ) × (C_S /C_U) × 100 

r_U = peak response from the Sample solution  

r_S = peak response from the Standard solution  

C_S = concentration of USP Albendazole RS in the Standard solution (µg/mL)  

C_U = nominal concentration of albendazole in the Sample solution (µg/mL) 

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS 

pH 〈791〉: 4.5–5.5 

5 ADDITIONAL REQUIREMENTS 

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

Labeling: Label it to indicate that it is for veterinary use only. 

USP Reference Standards 〈11〉 

USP Albendazole RS