Spectral characteristics of 5-hydroxymethylfurfural as a related substance in medicinal products containing glucose
Objectives: To study 5-hydroxymethylfurfural (5-HMF) spectral characteristics aiming at their future application in analytical procedures and their validation for the determination of 5-HMF in liquid products containing glucose after sterilization.Method: Direct spectrophotometric method for the determination of 5-HMF using the molar absorption coefficient at the absorption maximum (284 nm).Results and discussion: aqueous 5-HMF solutions have strong absorption in the ultraviolet range below 310 nm and give two absorption maxima at wavelengths of 229–230 nm and 284 nm. An excellent linear relationship between absorbance and 5-HMF concentration was observed in the concentration range of 2.0–1…
Approach of the State Pharmacopeia of Ukraine to analytical procedures validation on the example of chloride ions assay in peritoneal dialysis solutions
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…