Pamidronate disodium, a type of bisphosphoate drug, is used to treat hypercalcemia caused by drug malignant tumors, osteolytic bone metastasis of breast cancer, and osteodysplasia. According to the United States Pharmacopeia and the National Formulary (USP 43-NF 38*), quantification of pamidronate disodium should be carried out with a column with L23 packing material and meets following requirements. The IC I-524A confirmed the requirements were met.

System suitability requirements:
   Tailing factor of disodium pamidronate : ≥ 0.3, ≤ 1.2
   Relative standard deviation (RSD): ≤ 2.0%

*The version at the time of the application acquisition.


Sample : 100 μL
Pamidronate disodium 2 mg/mL dissolved in H₂O
1. Pamidronic acid

Column       : Shodex IC I-524A (4.6 mm I.D. x 100 mm)
Eluent       : 0.47 mL of Formic acid in 2500 mL of Water, pH3.5
               (adjusted with 2 N NaOH aq.)
Flow rate    : 1.0 mL/min
Detector     : RI
Column temp. : 35 °C