Risk assessments are a good thing and can make life easier in the pharmaceutical environment. Everywhere it is said that this or that has to be or has been defined "risk-based"...
Hmm, all well and good, but where are the potential applications in the validation of analytical methods?
We’d like to make a deep dive into this question in today's blog post.
Small book - small review ;-) ?
Well, not exactly...
I'm going to reveal myself now - as a fan of the “essentials” series! Therefore, I‘d like to talk today about the book "Validation of Bioanalytical Methods" by Patric U.B. Vogel, which was published in 2020 by Springer Spektrum, Wiesbaden (ISBN: 978-3-658-31951-9).
In lyophilizates of pharmaceutical drugs, the residual moisture content must be determined. It must be as low as possible in order to delay possible degradation reactions during storage and thus ensure the declared shelf life. Such a water determination can be performed applying the Karl Fischer titration. This titration method is a widely used procedure for quantitative water determination in a variety of samples and was developed by Karl Fischer in 1935. In the European Pharmacopoeia (Ph. Eur.), chapter 2.5.12 covers the volumetric (semi-micro) determination and chapter 2.5.32 covers the coulometric titration. The choice of method is primarily based on the amount of water present in the sample.
It seems I somehow might say: “No vacation without any technical book!”... Therefore, today's review is about the book “Validation in analytics” by Stavros Kromidas (2nd edition published by the Wiley-VCH Verlag GmbH & Co. KGaA Weinheim in 2011, ISBN: 978-3-527-32939-7).