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American Pharmaceutical News In Review
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July 31, 2020
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  Identifying & Mitigating Errors in Organic Extractables & Leachables Screening

The discipline of Organic Chromatographic “Screening” to discover, identify and (semi-)quantify organic compounds in an extract (from a pharmaceutical container closure system or from a medical device) or in a drug product is a relatively new concept. While the Chromatographic Screening process is the best solution to cover the three functions it should serve (discovery, identification and quantification), each function of the screening process is prone to errors that are inherent to the screening methodology. This FREE WEBINAR explains these errors in detail and addresses ways to minimize the occurrence of these errors or how to mitigate their impact on the final screening outcome.

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» Industry News
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  Immunic Begins IMU-838, Oseltamivir Trial for COVID-19
Immunic announced enrollment of the first patients in a trial of the company's selective oral DHODH ... read more »
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  Onconova Submits Application for Rigosertib to Participate in COVID-19 Human Studies
Onconova has submitted an application with the NIAID, with the goal of obtaining funding from the ... read more »
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  MediciNova Announces SARS-CoV-2 Vaccine Joint Development with BioComo, Mie University Japan
MediciNova announced an agreement with BioComo and Mie University for joint development of a SARS-... read more »
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  FDA Authorizes Test for People without Known, Suspected COVID-19 Infection
The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to include two new indications for use: ... read more »
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  Calquence Recommended for CHMP Approval for Chronic Lymphocytic Leukemia
AstraZeneca’s Calquence has been recommended for marketing authorization in the EU for the treatment... read more »
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  Reader Quiz: Drug Development Challenges
What are your greatest drug development challenges? read more »

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» Featured Articles
Solid Lipid Nanocarrier Development Toolbox for Increasing Oral Bioavailability of API
This article provides an overview of the processing techniques and the methods of characterization ... read more »
Fluidity Versus Certainty in Early Small Molecule CMC Development
The transition of a drug from optimized medicinal chemistry lead to candidate nomination and ... read more »
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» Infographic
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  Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take our 10-question quiz with your team to find out if you have the most efficient TOC monitoring program. read more »
» Featured Video
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  On-Demand Webinar: Making the Switch: The Evaluation, Implementation and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
In this webinar, you'll learn about Octapharma’s evaluation of the PCR method, as an alternative to the traditional growth-based mycoplasma testing ... watch »
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  Watch Video: Unchained Labs - Hound Demo
Unchained Labs - Hound Demo watch »

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» Featured Products
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  6000TOCi On-line TOC Analyzer
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  HT100 Tablet Testing System
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» Featured Whitepaper
eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »
From LAL to rFC Assays: A more sustainable future for endotoxin testing
Bacterial endotoxins are pyrogenic lipopolysaccharides found in the outer cell membrane of Gram-negative bacteria. Ubiquitous in the environment, endotoxins can easily enter the patient’s bloodstream ... read more »

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| Events
EVENT
  Advancements in the Characterization of Pharmaceuticals by DSC
Online –  09/02/2020
Differential Scanning Calorimetry is a simple, yet powerful technique to gain a broad understanding of the characteristics of pharmaceutical materials...
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EVENT
  Introducing the Latest Technology in Bioburden Testing
Online –  09/17/2020
This webinar will provide an in-depth review of the upgrades to the Milliflex Oasis Pump and consumables used in Bioburden Testing.
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