The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
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European Pharmacopoeia (Ph. Eur.)
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
The revised general chapter 5.21 has been published in Pharmeuropa 33.3, the European Pharmacopoeia online forum, for public comment.
The European Pharmacopoeia will put an end to the rabbit pyrogen test in the next five years and encourages industry to adopt the monocyte-activation test instead.
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
The EDQM and European Pharmacopoeia have decided to share Ph. Eur. quality standards for COVID-19 vaccine developers to support their research.
Lonza and Sanquin partner for commercialisation of specialised MAT reagents for accurate and reliable in vitro pyrogen testing
Lonza Sales AG, through its Bioscience Division has joined forces with Sanquin Reagents B.V. to enable drug developers and quality control laboratories to take full advantage of the power of the Monocyte Activation Test (MAT).
European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…
Globalisation has facilitated greater international harmonisation and standardisation of quality standards, which in turn has impacted on pharmacopoeias1. Historically, general chapters were developed based on input from local regions with little concern for global consequences. This often led to the development of similar, but unidentical tests, for example, Residue on…
The Milliflex® Quantum system (Merck Millipore) is a rapid method for the quantitative detection of contaminants in filterable samples...
Measurement and validation of the European Pharmacopoeia (EP) Colour scale.
3 September 2015 | By Michael J. Miller, PhD Microbiology Consultants, LLC
From 2010 to 2013, European Pharmaceutical Review published a very successful series on rapid microbiological methods (RMM) that included hot topics such as the European Medicines Agency’s and US Food and Drug Administration’s expectations, implementation strategies, scientific principles behind the technologies and validation.
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