Pharmaceutical Technology-11-01-2011

The US Pharmacopeia (USP) proposes to lower the maximum permissible limits of trace elements in pharmaceuticals and recommends that impurities be measured through automated instrumentation-based methods. The proposed regulations specify inductively coupled plasma–mass spectrometry (ICP–MS) and inductively coupled plasma–optical emission spectrometry (ICP–OES) as the techniques of choice. This article discusses the benefits of ICP–MS and ICP–OES for the accurate detection of trace elements in pharmaceutical products, in compliance with the proposed USP chapters.

The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs.

Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.

A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

This article focuses on the history of glass delamination and methods that detect it, both from a compendial and a research perspective.

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.

The authors describe the benefits of nuclear magnetic resonance (NMR) compared with traditional monitoring techniques. They also discuss how NMR reaction monitoring provides a new process analytical technology tool for industry.