Glucosamine is sold as a food supplement worldwide, but its production is poorly regulated. A direct and reliable method for the quality control of glucosamine in commercial products is of great importance. This article describes a simple, fast and validated ultra-performance liquid chromatography-quadrupole time of flight (UPLC-QToF) for the determination…
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19 October 2017 | By European Pharmaceutical Review
The European Pharmacopoeia chapter on methods for microbiological quality control was recently revised to include a number of significant changes. In this In-Depth Focus Michael Miller provides the first part of this two-part review and Kevin Williams discusses a paradigm change in biologics microbiological contaminant control.
18 October 2017 | By Tony Edge - Agilent Technologies
In the field of bioanalysis, the use of sample preparation is fundamental to ensuring that data is robust. This article looks at some of the various forms of sample preparation that are commonly used for the pre-treatment of biological fluids and considers the advantages and disadvantages of each approach.
18 October 2017 | By European Pharmaceutical Review
Welcome to European Pharmaceutical Review’s Guide to Outsourcing, the fourth in our series of ‘Guide to…’ supplements. In this edition, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.
17 October 2017 | By Kevin L Williams
Contaminant detection methods derived from the innate, proinflammatory responses of rabbits and Limulus blood have been used to determine the existence of microbial artefacts in small-molecule drugs (SMDs) and large-volume parenterals (LVPs) for decades...
17 October 2017 | By European Pharmaceutical Review
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
4 October 2017 | By Jean-Marie Aulnette
Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.
3 October 2017 | By Dr Zara Kassam (European Pharmaceutical Review)
As part of EPR's Women in Pharma series, Petra Wicklandt, Senior Vice President, Head of Global Chemical and Pharmaceutical Development, Merck, talks to Science Editor Dr Zara Kassam about facing challenges in the pharmaceutical industry and turning them into solutions...
3 October 2017 | By Dante J Marciani
Dante J Marciani, President and CSO of Qantu Therapeutics, reviews the current evidence and controversy in the hunt for a vaccine against Alzheimer's disease and considers the future.
31 August 2017 | By Dr Michael J. Miller
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…
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…