October 2024

Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.

In this article, the use of comprehensive two-dimensional liquid chromatography (LC×LC) coupled to mass spectrometry (MS) for characterizing glycosylation of therapeutic enzymes is presented.

It has been more than five years since the last update in this column on the evolution of the Hydrophobic Subtraction Model (HSM) of reversed-phase selectivity and characteristics of new stationary phases recently characterized using the model. In this installment, Dwight Stoll discusses the continuing evolution of the model.

This paper describes the content of a well-written analytical procedure for regulated high-performance liquid chromatography (HPLC) testing. A stability-indicating HPLC assay for a drug product illustrates the required components for regulatory compliance, including additional parameters to expedite a laboratory analyst’s execution.

Hydrophilic interaction chromatography–mass spectrometry (HILIC-MS) offers a flexible and efficient alternative to ion-pairing reversed-phase liquid chromatography (IP-RPLC) for oligonucleotide analysis, with column selectivity and mobile phase pH being key factors in optimizing retention and detection.

Click here to download the North America PDF of the LCGC International October 2024 issue.

Click here to download the Europe PDF of the LCGC International October 2024 issue.