Pharmaceutical Technology-10-02-2020

Pharmaceutical Technology

Development of a Validated Method of Testing for NDMA in Ranitidine

October 03, 2020

Peer-Reviewed Research

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This article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.

Improving Agility Through Scalability

October 03, 2020

Manufacturing

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Research is striving to make pharmaceutical processes more scalable by making them simpler and easier to replicate and control. Advances include 3D printing, as well as miniaturized and continuous processes, all of which are being aided by improved automation and analytics.

Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?

October 02, 2020

Regulatory Watch

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Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

Regulating with Flexibility: The Pandemic Effect

October 02, 2020

Regulatory Watch

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Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Fighting the (Dis)Information Pandemic

October 02, 2020

From The Editor

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Misleading messages contribute to eroding trust in public health agencies.

The Elephant (or Donkey) in the Room

October 02, 2020

From The Editor

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European pharma companies may have a vested interest in the outcome of the US elections.

Writing Effective SOPs

October 02, 2020

Ask the Expert

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The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

Automated Perfusion System

October 02, 2020

Product Spotlight

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Cytiva announced that it is launching the Xcellerex Automated Perfusion System (APS), a device aimed at simplifying processes and reducing risks when intensifying upstream operations.

Compact Capillary Electrophoresis System

October 02, 2020

Product Spotlight

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The Spectrum Compact CE System from Promega is a benchtop capillary electrophoresis (CE) instrument that allows users to perform sequencing and fragment analysis at the bench in laboratories of all sizes.