• 7 years Chromicent
    7 years of Chromicent – and we say a warm thank you to all our colleagues and companions, customers and friends, and especially to our team. And: Here’s to the next seven years! The setting is of course different in these times and the now traditional sitting together and feasting at a big table will … 7 years Chromicent
  • New publication: Nitrosamines
    The first detection of nitrosamines in valsartan preparations took place two years ago. Since then, it has become obvious that the problem of contamination of pharmaceutical products with nitrosamines is of greater consequence than initially assumed. In our follow-up publication in the renowned Journal of Pharmaceutical and Biomedical Analysis, we focus on the development of … New publication: Nitrosamines
  • BioAccord – Nitrosamines and more
    In response to the increasing demand for large molecule analyses, we at Chromicent are currently testing the BioAccord system from Waters. The background and further information on the BioAccord can be found *here*. In the past few months, we have been working intensively on various issues. Here is a brief overview of the most exciting … BioAccord – Nitrosamines and more
  • Ion Chromatography & Events
    Dear customers and friends of Chromicent, we would like to start by wishing you an happy new year. As you have come to expect from us, this year is off to an eventful start. We warmly welcome a new colleague to the team just in time for the beginning of the year. As a chemist … Ion Chromatography & Events
  • Merry Christmas
    Dear customers and friends of Chromicent, The Chromicent team wishes you a Merry Christmas, a peaceful holiday season and a Happy New Year.
  • News from the Chromicent
    Dear customers and friends of Chromicent, our information letter for autumn 2020 has been released. You will find it in the following for download as PDF: By using BioAccord, Chromicent takes the next step – and invites you to become part of it. In the coming months, we will offer you the opportunity for free … News from the Chromicent
  • Take the next step with us
    The Chromicent is now using a BioAccord system from Waters. What is special about it? BioAccord is a Ready to Use LC-MS system that enables high-performance biopharmaceutical analysis in a user-friendly and complete solution. Self-calibrating, self-optimizing, bioinert and equipped with intelligent software, the system is designed and optimized for routine use, for quality control and … Take the next step with us
  • Digitization – Key Topic of our Time
    September at Chromicent was all about digitalization. In cooperation with the HTW Berlin, we have subjected Chromicent to a digital checkup as part of the “Digital Plus” project to determine our level of digitization and test our performance. The result was clear: We are playing right at the top. Nevertheless, thanks to the use of … Digitization – Key Topic of our Time
  • EMA – Statement Nitrosamine
    The EMA has published a final statement on nitrosamine impurities in medicinal products. The full report can be found *here*. The publication of Chromicent is also mentioned: “A rather new approach has been published in May 2019 describing the simultaneous determination of related substances and N-nitrosamines in valsartan and losartan [Schmidtsdorff, Schmidt (2019)] in one … EMA – Statement Nitrosamine
  • News from the Chromicent
    Dear customers and friends of Chromicent, we have good news and would like to share it with you. You will find our detailed information letter Our summer topics:  Chromicent has invested: from now on size exclusion chromatography (SEC) is part of our portfolio. In addition, we will keep you informed about interesting and important webinars … News from the Chromicent
  • New: Size Exclusion Chromatography (SEC)
    Chromicent has enhanced its portfolio with size exchange chromatography (SEC). This chromatographic method enables us to separate molecules in solution by size (hydrodynamic volume) and to identify their relative molecular weight. The use of SEC in our laboratory routine serves the characterization of proteins, synthetic polymers and natural polymers, such as polysaccharides. The ability to … New: Size Exclusion Chromatography (SEC)
  • ICH Q2/Q14 Analytical Procedure Life Cycle Management
    This conference provides a comprehensive overview of the new ICH Quality Guideline Q14 on Analytical Procedure Development, and the revised Q2 Guideline on Validation of Analytical Procedures. Experts from authorities, industry and contract laboratories will discuss with you the contents, their significance for practice and approaches for implementation in your company. Highlights Regulatory Developments and … ICH Q2/Q14 Analytical Procedure Life Cycle Management
  • Analytical Design Space Modeling
    We are pleased to recommend another webinar: Analytical design space modeling in accordance with ICH Q12 and proposed Q14: Using a novel approach for in silico method development and robustness assessment 30. Juni 2020 – 16:00 BST / 17:00 CEST / 08:00 PDT / 11:00 EDT For the registration please click on the following link. … Analytical Design Space Modeling
  • Challenge: Nitrosamines
    In the field of pharmaceutical safety, nitrosamines remain a crucial issue. In a webinar entitled “Analysis of nitrosamines in APIs by LC/MS: How to face all challenges?” led by Arjan Timmerman, (Business Development Core Market), the Waters Corp. focused on the various analytical methods. Part of the webinar was also the method developed by Chromicent … Challenge: Nitrosamines
  • Method LifeCycle Management from Chromicent GmbH speeds up drug development considerably. Contribution of the Berlin-based company to coping with the “Corona crisis”
    Events such as the coronavirus pandemic make us aware that access to innovative, affordable and safe medicines is one of the challenges of our time for the rapidly growing world population. From its location in Berlin-Adlershof, Chromicent GmbH supports the pharmaceutical industry in the development of pharmaceuticals to combat and treat infections with the SARS … Method LifeCycle Management from Chromicent GmbH speeds up drug development considerably. Contribution of the Berlin-based company to coping with the “Corona crisis”
  • The current situation
    Dear customers and friends of Chromicent, the Chromicent, like all of us, faces great challenges. Our SOP “Pandemic Plan” was activated at the beginning of March. Our employees were informed about the current situation and sensitized to the existing risk of infection in three extensive training courses. Visitors no longer have access to our laboratories … The current situation
  • Nitrosamine
    In accordance with Article 31 of Directive 2001/83/EC, the EMEA expects all pharmaceutical manufacturers to provide information on nitrosamines contained in medicinal drugs by the end of March. In case of a corresponding risk assessment, there is a requirement to test drugs analytically, drugs with high risk immediately. As a consequence, Chromicent is receiving more … Nitrosamine
  • Nitrosamine – SFC capacity expanded
    Dear customers and friends of Chromicent, as you can see in our last year news, nitrosamines in active ingredients are still a hot topic ! Chromicent has significantly expanded its SFC capacities with a further WATERS ACQUITY UPC2 system to meet the demand for nitrosamines analysis using our developed, validated and published SFC-MS/MS method. The … Nitrosamine – SFC capacity expanded
  • Food and Environmental Forum 2020
    Chromicent is pleased to present our method for the detection of pyrrolizidine alkaloids by LC-MS/MS and SFC-MS/MS developed by our project manager Maike Rehn at the Food and Environmental Forum 2020. Save the Date: 05. und 06. Mai 2020 Abstract Insights into method development for the determination of pyrrolizidine alkaloids – UPLC vs. UPC2 Pyrrolizidine … Food and Environmental Forum 2020
  • The Chromicent wishes you a happy new year!
    Dear customers and friends of Chromicent, we wish you a successful new year and start with good news: At the end of 2019, the local drug authority carried out an GMP-inspection according to EU regulation. Chromicent was certified as having an exceptionally high level of quality and the GMP compliance confirmation was issued with expected … The Chromicent wishes you a happy new year!
  • Merry Christmas and a successful 2020!
    Dear customers and friends of Chromicent, we look back with pleasure on a successful year and would like to take this opportunity to thank you for the trust you have placed in us, your support and your joint work. The Chromicent team wishes you a Merry Christmas and a Happy New Year.
  • QbD-Lecture at the University of Pavia
    The University of Pavia near Milan is one of the oldest, most prestigious and, if we may say, most beautiful European universities. Their history dates back to the 16th century. Thus, it was a special pleasure for Chromicent’s CEO’s – Mijo Stanic and Dr. Alexander H. Schmidt – to follow the invitation of Prof. Dr. … QbD-Lecture at the University of Pavia
  • Valsartan – new analysis method with SFC
    Our SFC specialist Sebastian Schmidtsdorff has developed a new method for testing sartans for contamination by nitrosamines. Our analysis using SFC-MS / MS is now available and includes eight other nitrosamines besides the mostly problematic NDMA and NDEA. The method is qualified and ready for use by Chromicent laboratories. The publication can be found under … Valsartan – new analysis method with SFC