Azithromycin is a 15-membered ring macrolide antibiotic. According to the United States Pharmacopeia and the National Formulary (USP 39-NF 34*), ”ASSAY" for "Azithromycin" should be carried out with a column filled with L67 packing material. The Asahipak ODP-50 4E, a column filled with L67 packing material, confirmed the requirements were met.

System suitability requirementsResolution of azaerythromycin A and azithromycin (System suitability solution): ≥ 3.0
Tailing factor of azithromycin (Standard solution): 0.8 - 1.5
Relative standard deviation of of azithromycin (RSD) (Standard solution): ≤ 1.10%

*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) 0.53 mg/mL of Azithromycin (prepared according to USP-NF method)
(System suitability solution) 0.5 mg/mL each of Azithromycin and Azaerythromycin A (prepared according to USP-NF method)

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