Analytical Method Development

Jan 02, 2017
Pharmaceutical Technology
The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
Dec 07, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.
Nov 02, 2016
Pharmaceutical Technology
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
Aug 02, 2016
Pharmaceutical Technology
This paper describes a unique Prep-RP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
May 02, 2016
Pharmaceutical Technology
The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.
Apr 02, 2016
Pharmaceutical Technology
Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
Apr 02, 2016
Pharmaceutical Technology
A scientific approach to calibration and routine testing of balances ensures accurate results.
Feb 01, 2016
New technologies must meet the speed, sensitivity, and safety demands of emerging bio/pharmaceuticals.
Aug 01, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.
May 27, 2015
Pharmaceutical Technology
By Pharmaceutical Technology Editors
While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.
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