Analysis of Pamidronate Disodium According to USP-NF Method (IC I-524A)

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*), "ASSAY" for "Pamidronate Disodium" 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 (Standard solution): 0.3 - 1.2
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 100 µL
(Standard solution) Pamidronate disodium 2 mg/mL in H2O

  1. 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 ℃

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