Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
News|Articles|May 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-06-03-2015
- Volume 11
- Issue 6
Titration Systems Configured for Single-Analyte Testing
Potentiometric titration systems from Metrohm can be customized for different applications.
The Metrohm Titration Analyzer Systems are potentiometric titration configurations for single-analyte testing that can be customized to different needs of the laboratory. After the proper electrode, user-interface, and titration conditions for an analysis method are determined through a consultative process, a unique analyzer configuration is established for the method. Systems can be controlled from the company’s Tiamo computer software or from a touchscreen interface.
The single-row 855 titration analyzer system with an integrated autosampler occupies less than two linear feet of bench space and was developed to improve productivity for applications that have a low sample count or for analyzing a high-volume samples. Multi-row configurations, for higher sample counts or lower analysis volumes, are also available.
Source:
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Kit Detects and Quantifies HCPsover 11 years ago
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Small-Molecule APIs Still Play a Big Roleover 11 years ago
CMOs in Asia Gain Market Share, Slowlyover 11 years ago
Safety Testing on the Manufacturing Floorover 11 years ago
Advances in Continuous Crystallizationover 11 years ago
Keeping Up with Biologics AdvancesRelated to this article
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
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