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November 05, 2021

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The Need for High-End Analytical Technology to Assess Low Concentration Levels in LVP Screening

Screening results for large volume parenteral (LVP) applications need to be evaluated at low concentration levels. The reported list of extractables and leachables is often extensive, and a correct identification of each of the reported compounds is key to allow an accurate and comprehensive toxicological assessment. Learn more about good identification practices in first-pass evaluations and how to increase the identification level of unknown or only partially identified compounds in second-pass evaluations.

	Industry News

FDA Advisory Committee Votes in Favor of EUA for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to 12 Years
Pfizer and BioNTech announced that the FDA Vaccines and Related Biological Products Advisory ... read more »

FDA Announces Availability of Portal and Draft Guidance on Reporting Amount of Listed Drugs and Biological Products
The FDA announced the new use of a NextGen Portal for reporting the annual amount of listed human ... read more »

AstraZeneca to Transfer Rights for Eklira and Duaklir to Covis Pharma
AstraZeneca has agreed to transfer its global rights to Eklira (aclidinium bromide), known as ... read more »

Pfizer and BioNTech Receive First FDA EUA for COVID-19 Vaccine in Children
Pfizer and BioNTech announced that the FDA has authorized for emergency use the Pfizer-BioNTech ... read more »

	Infographic

5 Tips to Help Choose the Right TOC Sensor
Fast, continuous measurement of Total Organic Carbon (TOC) with an on-line analyzer allows real-time water release and ensures rapid detection of even... read more »

	Featured Articles

Fused Deposition Modelling: 3D Printing Technique on the Verge to Create Booming Growth in Pharmaceuticals The pharmaceutical sector is on the brink to join the fourth industrial revolution. It also allows clinicians to develop better-performing medical ... read more »

Clarifying and Meeting the Requirements of 21 CFR Part 11 and Data Integrity for Dissolution Testing Since the release of the latest FDA guidance documents on 21 CFR part 11 and data integrity, there has been much confusion regarding what is required ... read more »

	Featured Video

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

	Featured Products

Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform
read more »

	Featured Whitepaper

eBook: Microbial Identification - Trends and Technologies for Aseptic Manufacturing Facilities
eBook content includes a wide variety of topics for microbial identification in pharmaceutical facilities. Strategies, tools, and technologies are featured. Articles feature an analysis of FDA ... read more »

	Events

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... event details »

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