Chromatography :
Teledyne LABS has pushed the envelope in the automation of sample purification in synthetic and natural product chemistry labs for over 30 years. We are globally known as a pioneer in the research, development and construction of flash chromatography, preparative high-performance liquid chromatography and supercritical fluid chromatography instruments, related products and services.
Our instruments are ideal for the purification of organic compounds, featuring top-tier sample recovery in normal-phase and reverse-phase separations. Teledyne LABS chromatography systems are practical, easy to use, and put your mind at ease with trustworthy, repeatable results. All that and more, yielding big performance packed into an exceptionally small footprint to conserve precious space in your lab.
Pumps:
Whether in the lab, through scale-up, or in production, where precise, repeatable dosing is a demand, pumps from Teledyne LABS are ideal for continuous flow pharmaceutical applications. In many chemical reactions that occur during research and development of new medications, consistent flow rate is a key to success. Teledyne LABS pumps unlock your potential with a lineup of long-lasting, reliable solutions.
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Product development — Precise fluid delivery (± 0.5% or better) to produce high-quality results
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Process development/pilot scale/production — High repeatability, with pulseless flow for troubleshooting and proof of concept
TOC applications:
The United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) require Total Organic Carbon (TOC) testing of purified water and water for injection (WFI).
A correlation is believed to exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and within pharmaceutical testing and distribution systems. Introduction of organic matter into water systems occurs not only from living organisms and decaying matter in source water, but also from purification and distribution system matter.
Maintaining low TOC levels helps to control the degree of endotoxins and microbes, inhibiting the development of biofilm growth. For this reason, TOC is universally accepted as critical to monitoring purification and distribution system performance for process control in biotechnology.
Because these biotechnology operations include the preparation of medicines, the Food and Drug Administration (FDA) prescribes numerous regulations to protect public health, assure drug efficacy and maintain consistent product quality. To ensure there is no cross-contamination between product runs of dissimilar drugs, various cleansing procedures are performed. TOC concentration levels are measured to track the success of these cleaning validation procedures, specifically
clean-in- place (CIP).
Sample handing/sample introduction accessories for ICP-AES and ICP-MS
With the January 2018 implementation of USP <232>/<233>, detailing the testing criteria for measuring elemental impurities in finished drug products, manufacturers must change from traditional wet chemistry methods to recommended instrumental techniques, such as inductively coupled plasma atomic emission spectrometry (ICP-AES) or inductively coupled plasma mass spectrometry (ICP-MS).
Teledyne LABS offers a range of sample handling and sample introduction instruments for ICP-AES and ICP-MS that strictly adhere to USP <232>/<233>, enabling improved analysis of drug products for results you—and regulators—can count on.
