Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
News|Articles|March 2, 2016
- Pharmaceutical Technology-03-02-2016
- Volume 40
- Issue 3
Confocal Microscope for Surface Analysis
The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories.
The Zeiss Smartproof 5 wide-field confocal microscope is designed for applications in quality assurance and quality control, production, and R&D laboratories. The microscope system provides 3D reconstructions and roughness measurements for work piece surfaces.
The microscope has an embedded optics, electronics, and camera minimizing the number of cables used. Smartproof 5 can be installed and run in different working environments without anti-vibration equipment. The machine can also complete roughness analyses in 2D (profile) and 3D (area)--both based on ISO standards. The Smartproof 5’s software provides easy-to-operate workflow routines, and a graphical user interface guides users through recurring tasks, ensuring user-independent data acquisition.
Articles in this issue
over 10 years ago
Gaining Insight from Process Control Dataover 10 years ago
Phase-Appropriate GMPover 10 years ago
How Important is Data Integrity to Regulatory Bodies?over 10 years ago
FDA GDUFA Testimony Presentation Slidesover 10 years ago
Keynote Series Addresses Crucial Industry Issuesover 10 years ago
Polymorph Screening for Identification of Relevant Crystalline Formsover 10 years ago
Building Consensus for E&L Testing Standardsover 10 years ago
Multimode Microplate Reader Improves SensitivityRelated 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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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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