Pharmaceutical Technology, Nov 1, 2011 - Pharmaceutical Technology

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Pharmaceutical Technology, Nov 1, 2011
Articles
The Causes and Implications of Glass Delamination
By Ronald G. Iacocca
This article focuses on the history of glass delamination and methods that detect it, both from a compendial and a research perspective.
An Analytical Technique for Identifying Tribromoanisole
By Roger J. Bleiler , Fred Kuhrt , Don Wright
Combining olfactometry analysis with multidimensional gas chromatography–mass spectrometry provides an extremely useful analytical method for identifying aroma or odor notes from a sample.
Addressing Elemental Impurity Limits with ICP–OES and ICP–MS
By Matthew Cassap
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.
NMR Reaction-Monitoring as a Process Analytical Technique
By David A. Foley , Mark T. Zell , Brian L. Marquez , Andreas Kaerner
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.
Evaluating the Bioequivalence of Antibody–Drug Conjugates
By Monica Whitmire , Alan Breau
The authors discuss the analytical methods and related testing for bioequivalence studies of ADCs.
Protein Sensitivity to Tungsten
By Vinod Vilivalam , Lloyd Waxman , Tadd Steeley
The authors investigate the effect of low pH and ionic strength on aggregation using turbidity measurements and size-exclusion–high-performance liquid chromatography.
Inhaled Product Characterization
By David Lewis , Mark Copley
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.
Analytical Applications
A Technical Forum Moderated by Patricia Van Arnum, featuring contributions from PerkinElmer, BioTools, Chiral Technologies, Shimadzu Scientific Instruments, GE Analytical Instruments, and Waters.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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Expedited reviews of drug submissions
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More stakeholder involvement
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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