The monograph below became official on May 1, 2025.

Bisphosphonate is a drug which prevents bone resorption, and thus used for osteoporosis treatment. According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 47(6)*), "ASSAY" for "Ibandronate Sodium" should be carried out with a column filled with L23 packing material. The IC I-524A, a column filled with L23 packing material, confirmed the requirements were met.

System suitability requirementsTailing factor (in Standard solution): ≤ 2.5
Relative standard deviation (RSD) (in Standard solution): ≤ 0.73%

*The version at the time of the application acquisition.

Sample: 40 μL
(Standard solution) Ibandronate sodium 2 mg/mL in water

1. 1.Ibandronate