Pharmaceutical Analysis

This eBook contains a selection of application notes relevant for pharmaceutical and biopharmaceutical analysis using HPLC / (U)HPLC or LC-MS/MS.

Separation Science, in collaboration with Shimadzu, offers a series of application notes describing the quantitation of various nitrosamines in drugs and solvents using its LC/MS or GC/MS instruments. Click below to download your personal copies.

In this application note, a Thermo Scientific™ HR-MAM workflow for biosimilarity assessment is evaluated. The study demonstrates the use of the workflow for sequence variant assessment and to monitor the variability of product quality attributes in...

Separation Science, in collaboration with Thermo Fisher Scientific, offers a selection of application notes relevant for biopharmaceutical analysis. Discover the latest advances in high-resolution accurate-mass (HRAM) mass spectrometry. Learn more...

Separation Science, in collaboration with Phenomenex offers an on-demand webinar 'HPLC/UHPLC Reversed-Phase Method Development: Selecting a Reproducible Starting Point' with pharma industry expert, Dr Phil Koerner.

This application note will help you understand how trap-free 2D LC-MS allows online conversion of non-volatile to volatile mobile phase conditions and how the LCMS-9030’s high mass accuracy can be used to conduct structural analysis of impurities.

In this study, a successful micro LC-MS/MS method for the highly sensitive quantitation of desmopressin in human plasma is demonstrated. It shows how the QTRAP^® 6500+ LC MS/MS system with OptiFlow™ Source coupled with a M5 MicroLC system provides...

This study describes in detail an improved immunoaffinity-micro LC-MS/MS workflow for quantifying trastuzumab emtansine in mouse plasma using the SCIEX 6500+ QTRAP^® System with OptiFlow™ Turbo V source and M5 MicroLC System.

SCiEX has produced a technical note describing an immunoaffinity-high resolution accurate mass assay for the pre-clinical quantification of Trastuzumab in rat plasma.

Find, Identify and Confirm Peptide Catabolites Using MetabolitePilot^TM 2.0 Software and the Advanced Biotransform Solution.

SCIEX has produced a technical note describing metabolite identification of payload species of antibody drug conjugates with noncleavable linkers using MetabolitePilot™ 2.0 software and TripleTOF^® 6600 systems.

Peptide mapping is critical for characterizing protein drugs and monitoring product critical quality attributes (CQAs) in biopharma. Due to the heterogenous nature of protein drugs, comprehensive analytical characterization is required for getting...

This technical note from SCIEX will highlight how to implement a complete and easy-to-use Multiple Attribute Methodology (MAM) workflow for biotherapeutic PQA monitoring using accurate mass LC–MS. It will demonstrate how this new streamlined MAM...

Agilent Technologies has produced an application note describing the separation and purification of acetaminophen (paracetamol) and six common impurities listed in the European and United States Pharmacopoeias.

Rapid development of sensitive and selective peptide bioanalytical methods are required to support the expanding protein component of pharmaceutical companies’ drug pipeline. Choosing the best MRM for a large molecule peptide or protein is a...