Search results for "chlorides assay"
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Approach of the State Pharmacopeia of Ukraine to analytical procedures validation on the example of chloride ions assay in peritoneal dialysis soluti…
2019
The objective of this study was to develop and validate an alternative analytical procedure for the total chloride assay in solutions for peritoneal dialysis (PD). The proposed analytical procedure was validated according to the requirements of the International Conference on Harmonization (ICH) Guideline: Topic ICH Q2(R1) and the approach of the State Pharmacopeia of Ukraine (SPU). The analytical procedure was specific. The li-nearity of the procedure was evaluated in the concentration range of 76 to 114 mmol/L of chloride ions (80-120% of the stated content (95 mmol/L)) with the regression equation y = 1.0029 ∑ X -0.2269 and a correlation coefficient of 0.9989. The y-intercept of the regr…