Pharmaceutical Technology Europe-03-02-2019

Pharmaceutical Technology Europe

Quantification and Characterization of Polysorbate-80 in Protein Formulations

March 02, 2019

Features

2019 Supplement

1

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.

Pharmaceutical Technology Europe 2019 Outsourcing Resources Supplement (PDF)

March 02, 2019

Issue PDF

2019 Supplement

1

Click the title above to open the Pharmaceutical Technology Europe 2019 Outsourcing Resources Supplement in an interactive PDF format.

Utilizing Spectral Analysis in HPLC Diode Array to Discover Impurities

March 01, 2019

Features

2019 Supplement

1

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.