The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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Former MHRA inspector Rachel Carmichael discusses outsourcing areas of your quality system including what would drive this decision, aspects of the operation that can be supported and measures to facilitate the process
This article delves into four health technology assessment agencies, analysing the opportunities and challenges for orphan drugs in France, Germany, England and Scotland.
Learn why Ozonia MEMBREL electrolytic ozone technology is the ultimate solution for ultrapure water disinfection applications.
Learn the benefits of Ozonia MEMBREL electrolytic ozone technology in ultrapure water disinfection applications.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
Since making its debut in the pharmaceutical setting, the range of applications for which Raman microscopy imaging has been used continues to grow. Here, Harald Fischer, Damon Strom, Miriam Boehmler, Eleni Kallis and Thomas Dieing demonstrate the versatility of confocal Raman imaging by exploring a variety of real-world applications.
The impact of rapid microbiological methods (RMM) on the scientific community has been widespread and profound. Lucpah Nekati explains how their numerous benefits enable deeper understanding, faster and more easily.
Application note: Pharmaceutical analysis using UV-Vis: compliance with USP Chapter <857> and European pharmacopoeia (Ph. Eur. Chapter 2.2.25)
USP general chapter and Ph. Eur. chapter 2.2.25 guide instrument operational qualification protocols for UV-Vis spectroscopy. This technical note demonstrates how to ensure qualification of the Cary 3500 as per global pharmacopoeias' requirements.
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
bioBoaVista showcases its viral transport medium, that can stabilise samples, for efficient nasal tests for the diagnosis of COVID-19.
A new consortium has been formed for the study of COVID-19 vaccines after their approval, to monitor their safety and efficacy.
After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
Reliable data integrity tools to take control of your equipment and data.