| EXTRACTABLES AND LEACHABLES |
Steven A. Zdravkovic
Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.
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| PEER-REVIEWED RESEARCH |
Ester Lovsin Barle, Camille Jandard, Markus Schwind, Gregor Tuschl, Claudia Sehner, David G. Dolan
In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
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| TROUBLESHOOTING |
Matt Bundenthal
Learn how to prevent common causes of product loss.
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| OUTSOURCING OUTLOOK |
Jim Miller
CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
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| US REGULATORY WATCH |
Jill Wechsler
Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
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| ASK THE EXPERT |
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to gain benefits from interactions with industry associations.
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| PRODUCT SPOTLIGHT |
The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines' OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.
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The portable Flexible Screw Conveyor from Flexicon can be tilted and rolled to serve multiple functions.
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The LogTag UTRID-16 Data Logger System from CiK Solutions GmbH includes a built-in USB connector, automatic PDF report generation, and six-level multi-alarm display.
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Ross Engineering's ASME tanks are custom built to serve a wide range of applications and processing requirements.
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