Evaluation of Measurement Uncertainty for the Determination of Pamidronate Disodium for Injection by Ion Chromatography

OBJECTIVE To evaluate the measurement uncertainty for the determination of pamidronate disodium for injection by ion chromatography, and find out the effect factors. METHODS The mathematical model was established, and the uncertainty was appraised according to JJF1059.1-2012. The various measurement uncertainties were quantified, and the evaluation results of measurement uncertainty were drawn. RESULTS The combined uncertainty was 0.989%, the expanded uncertainty was 1.98%，and the content of pamidronate disodium was (99.29±1.98)% (k=2). CONCLUSION The uncertainty originates primarily from the stability of ion chromatography, the repeatability and the reference substance. This uncertainty evaluation method can be used for uncertainty analysis in the determination of pamidronate disodium for injection by ion chromatography.