Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.
HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.
Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.