Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
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The water content of pharmaceuticals strongly influences their quality, shelf-life, and stability as well as the release of the active substances. The determination of water content is, therefore, vital in pharmaceutical analysis.
The Chestny ZNAK is a national track & trace system created by the Center for Research in Perspective Technologies.
CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.
Application note: Comprehensive cell culture profiling of iPS cells using LCMS Q-TOF – simultaneous analysis of SIM and Scan mode in a single run
In this work we report the metabolic analysis of cell cultures using a high-resolution accurate mass LCMS/MS Q-TOF platform to identify metabolite markers of genomics and phenotypic changes.
Whitepaper: Hydrogen peroxide: Is material compatibility a real challenge for this decontamination technology?
One of the most important challenges of the hydrogen peroxide technology has traditionally been the material compatibility.
Get some hints on how you can optimize the most time-demanding steps in your lab.
Your Global Drug Development Organization For Analytical Laboratory Testing and Clinical Research.
What’s the difference between High Performance Liquid Chromatography (HPLC) and Ion Chromatography (IC)? What are the capabilities and limitations of each technique? Knowing these differences can actually make a huge difference.
Whitepaper: A study of the peristaltic life and pumping performance of three TPE tubing products to assess their suitability for continuous bioprocessing
Drug manufacturers are increasingly adopting continuous bioprocessing to manufacture biologics as efficiently as possible. This is being driven by a need to reduce production costs and prices of pharmaceutical products. Furthermore, the FDA has stated its support for the implementation of continuous bioprocessing. A key consequence of continuous bioprocessing is…
Most laboratories today now have some form of LIMS to help manage their workflow. There are many types of LIMS, ranging in complexity from spreadsheets to intelligent programs that manage nearly every lab function.
Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability. Industry guidelines such as ALCOA and ALCOA+ describe these requirements, which are used by the FDA, WHO, PIC/S and GAMP. All major Metrohm software products make compliance with the ALCOA and…
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
The characterization of novel therapeutics involves many chemical processes.
LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.