Drug Substance Analysis

Oct 02, 2018
Pharmaceutical Technology
Integration of new modeling and analytical tools with flow chemistry are notable trends.
Sep 04, 2018
By Pharmaceutical Technology Editors
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
Aug 01, 2018
Pharmaceutical Technology
Determining how much containment is needed for API handling requires evaluation of multiple factors.
Jul 19, 2018
By Pharmaceutical Technology Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 02, 2018
Pharmaceutical Technology
Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.
May 02, 2018
Pharmaceutical Technology
Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.
Apr 04, 2018
By Pharmaceutical Technology Editors
A new book published in response to new USP chapters and ICH Q3D guidelines on measuring elemental impurities provides a practical guide for using plasma spectrochemistry for pharmaceutical analysis.
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