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QA/QC Drug Manufacturing Process

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  • Guide

    Safeguarding the Authenticity of Herbs & Spices

    Infrared (IR) and near-infrared (NIR) spectroscopy are fast, easy-to-use techniques with a history of being used for food applications such as those for measuring protein, moisture, and fat content. Food fraud and adulteration has become of particular concern to the industry over the past few years following reports of incidents in the media, with herbs and spices identified as one of the key problem areas.

  • White Paper

    Streamlining Materials Innovation Processes with Electronic Lab Notebook (ELN) and Data Analytics for Optimum Efficiency

    This paper explores the numerous challenges materials scientists and engineers face, from the time it takes to bring new materials to market to the difficulties delivering suitable formulations and testing against specified criteria, and how those can be resolved.

  • Application Note

    Trace Metals in Waters by GFAAS, in Accordance with U.S. EPA and Health Canada Requirements

    Precise and accurate measurements at the regulated levels are an important factor for assuring safe drinking water. U.S. EPA Method 200.91 is the method cited by EPA, Health Canada, and the WHO for the use of graphite furnace atomic absorption spectroscopy (GFAAS). In evaluating a GFAAS system for determination of these elements, it must provide good sensitivity, low noise, limited drift, and accuracy in matrices with high salt content (hard water) that might be found in drinking waters. In this work, the PinAAcle™ 900T, with a unique optical system, is evaluated for the use of EPA Method 200.9 for As, Cd, Pb, Se, and Tl in drinking waters.

  • Application Note

    Using FIMS to Determine Mercury Content in Sewage Sludge, Sediment and Soil Samples

    In this work, samples were digested with aqua regia using reflux conditions according to DIN method 38414. After proper dilution of the digested sample solution, Hg was measured interference-free using SnCl2 as the reductant. The recoveries of spiked mercury in sewage sludge samples ranged from 96 to 100%. The method was checked by the analysis of standard reference materials. All results were in agreement with certified values. The RSD for three replicates was approximately 2% at 10 µg/L Hg level.

  • Application Note

    Contrast-enhanced Imaging of Vasculature and Soft Tissues Using the Quantum GX MicroCT System

    X-ray CT imaging is commonly used for skeletal imaging as bones are densely mineralized tissues with excellent x-ray attenuation properties. In contrast, soft, less dense tissues often prove to be challenging to image due to their lack of sufficient tissue density. Soft tissues such as muscle, blood vessels and internal organs share similar x-ray attenuation characteristics and are not distinguishable under typical CT settings. In order to introduce density that would improve soft tissue contrast, several contrast agents have been developed for use in clinical and preclinical settings. This application note outlines the use of iodine and nanoparticle-based contrast agents for imaging soft tissues and vasculature in various organs using the Quantum GX to gain further insights into disease and therapeutic response.

  • Application Note

    Testing and Validation of Various Antacids for Elemental Impurities using the NexION 2000 ICP-MS

    The United States Pharmacopeia (USP) has announced that its new standards for elemental impurities in drug products will be implemented on January 1, 2018. General Chapters <232> and <2232> specify the list of elements and their permissible daily exposure (PDE) limits based on the route of administration.

  • Application Note

    Analysis of Cerium Dioxide Nanoparticles in Soil Using Single Particle ICP-MS

    This work demonstrates a robust method using SP-ICP-MS technology to detect CeO2 NPs which were extracted from soil samples with tetrasodium pyrophosphate (TSPP). Over the past few decades, engineered nanoparticles (ENPs) have been increasingly used in many commercial products. As a result, more and more ENPs have been released into the environment, which raises concerns over their fate, toxicity and transport therein.

  • Application Note

    MicroCT Investigation of Bone Erosion and Deformation in an Osteoarthritic Rat Model

    Osteoarthritis (OA) is the most common form of arthritis and affects a considerable portion of the elderly population. In the U.S., it is estimated that more than 630 million people worldwide have this chronic condition, generally in the knees. OA occurs when the cartilage that cushions the ends of bones within the joints gradually deteriorates, causing synovitis and joint deformation.

    The goal of OA research is to identify new therapeutic strategies that could prevent, reduce, halt progression, or repair the existing damage to the joint. Non-invasive in vivo imaging such as microCT is the standard modality for bone research due to its ability to obtain high-resolution images at an x-ray dose low enough as not to harm the animal. This makes microCT ideal for monitoring disease progression and response to treatments in the same animal over time. However, microCT data visualization and analysis can be cumbersome and time consuming. In this application note, we compared standard microCT software and advanced bone software to investigate bone erosion in an OA rat model.

  • Application Note

    Analysis of Pb, Dc, and As in Spice Mixtures

    With an inherent toxicity, a tendency to accumulate in the food chain and a particularly low removal rate through excretion, lead (Pb), cadmium (Cd) and arsenic (As) cause harm to humans even at low concentrations.

  • Application Note

    Imaging Hepatocellular Liver Injury using NIR-labeled Annexin V

    Drug induced liver injury (DILI) is a major reason for late stage termination of drug discovery research projects, highlighting the importance of early integration of liver safety assessment in the drug development process. A technical approach for in vivo toxicology determination was developed using Acetaminophen (APAP), a commonly used over-the-counter analgesic and antipyretic drug, to induce acute hepatocellular liver injury.

  • Application Note

    Stem Cell Research and Regenerative Medicine

    With the potential to treat a wide range of disease, from organ damage to congenital defects, stem cell research and tissue engineering form the underlying basis of regenerative medicine. Significant advances in the science of skin regeneration, for example, have now made it possible to develop and grow artificial skin grafts in a lab for treatment of burn victims. Other therapeutic applications include the use of stem cells to treat and repair central nervous system diseases such as ischemia and cerebral palsy, cardiovascular diseases, as well as autoimmune diseases including type I diabetes.

  • Application Note

    Discrimination of Herbal Lifestyle Products Using AssureID SIMCA and COMPARE Algorithms

    Herbal lifestyle products are widely used as alternatives to medicines around the world, with as many as 80% of people using them as a primary source of healthcare in developing countries. These treatments are commonly regarded by scientific papers, and on some occasions the media, as being inferior to orthodox treatment. This is due to the variation between herbal formulations which will not be present in so called ‘single-chemical’ drugs. The reasons for the aforementioned variation involve several factors including storage, environmental conditions, handling and unintentional or intentional contamination (adulteration).

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1-12 of 89 Products & Services

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  • NexION 2000 ICP-MS

    NexION 2000 ICP Mass Spectrometer

    PerkinElmer’s NexION® 2000 is the most versatile ICP-MS on the market, featuring an array of unique technologies that combine to deliver the highest performance no matter what your analytical challenge. Discover the effortless versatility of an instrument that makes it easy to handle any sample matrix, any interference, and any particle size.

    PerkinElmer received on April 11, 2018 the Application Award from LaborPraxis in the category Bio and Pharma Analysis for the NexION 2000 ICP-MS. We were awarded this prize during analytica 2018 in Munich, Germany, in acknowledgment of a new technique enabling users to quantify the amount of metal in an individual cell for the first time.
  • Quantum GX2 microCT imaging system

    Quantum GX2 microCT Imaging System

    Image beyond bone – into oncology, cardiovascular and pulmonary diseases, and much more, with the Quantum GX2 microCT imaging system. With the Quantum GX2, flexibility is key. Combining the ability to perform high speed, low dose scans, ideal for longitudinal studies, across multiple species (mice, rats, rabbits) with high resolution ex vivo scanning, the Quantum GX2 microCT imaging system offers the flexibility and performance you need to not just image, but further understand your disease models.
  • NexION 1000B ICP-MS

    NexION 1000 ICP Mass Spectrometer

    The NexION® 1000 ICP-MS is the ideal high-throughput system for routine, multi-elemental, trace-level analyses that meet regulatory standards – and that works within your budget. It features a host of proprietary technologies that combine to deliver exceptional speed and operational simplicity, making your lab more efficient than ever before.
  • Spectrum Two N FT-NIR Spectrometer

    Spectrum Two N FT-NIR Spectrometer

    The Spectrum Two N is a high-performance, yet robust and transportable FT-NIR system platform enabling simple, reliable NIR analyses. It’s the perfect system for labs that need to combine high-end performance with the ease-of-use features of a portable instrument, allowing users with different levels of expertise, from novice to seasoned professionals, to be proficient with it in no time.
  • PinAAcle 900T Atomic Absorption Spectrometer

    PinAAcle 900Z Atomic Absorption Spectrometer

    For laboratories needing a high-performance furnace-only atomic absorption (AA) spectrometer, the PinAAcle 900Z is a longitudinal Zeeman system with a true double-beam design for fast start-up and exceptional long-term stability.
  • PinAAcle_900T

    PinAAcle 900T Atomic Absorption Spectrometer

    For laboratories needing the best in both flame and THGA furnace atomic absorption (AA), the PinAAcle 900T is a combined flame/longitudinal Zeeman furnace system.
  • IVIS Lumina XRMS 2D Optical Imaging System with Integrated X-ray

    IVIS Lumina XRMS In Vivo Imaging System

    Industry leading Fluorescence, Bioluminescence and X-Ray Imaging - All-In-One benchtop instrument! The IVIS® Lumina XRMS (x-ray multi-species optical imaging system) adds to the versatility of the IVIS Lumina XR by offering the flexibility to image large animals up to 500 grams with precise optical and X-Ray overlay.
  • IVIS Lumina HT High Throughput Benchtop 2D Optical Imaging System

    IVIS Lumina III In Vivo Imaging System

    The IVIS® Lumina Series III brings together years of leading optical imaging technologies into one easy to use and exquisitely sensitive bench-top system.
  • EnVision 2105 multimode plate reader

    EnVision 2105 Multimode Plate Reader

    The EnVision 2105 multimode plate reader provides exceptional speed, ultra-high throughput, and maximum sensitivity across all detection technologies. Tried and tested, the EnVision microplate reader gives you robust performance and reliable data for high throughput screening, time after time.

    The EnVision 2105 model delivers even higher sensitivity for time-resolved fluorescence (TRF) applications, and the Enhanced Security software option includes tools to facilitate 21 CFR Part 11 compliance for integration into regulated environments (GxP). In addition, the Alpha 775 laser module is designed for plant assays.

  • 1000x1000_Opera_Phenix

    Opera Phenix High-Content Screening System

    The Opera Phenix High Content Screening System is the premier confocal solution for today's most demanding high content applications. Drawing on over a decade of experience with the industry-leading Opera® High Content Screening System, the Opera Phenix is designed for high-throughput, phenotypic screening and assays involving complex disease models, such as live cells, primary cells and microtissues.
  • IVIS SpectrumCT 2D/3D Optical/CT In Vivo Imaging System

    IVIS SpectrumCT In Vivo Imaging System

    The IVIS® SpectumCT preclinical in vivo imaging system expands upon the versatility of the IVIS Spectrum by offering 2D and 3D imaging capabilities but includes integrated low-dose microCT ideal for longitudinal studies. The system provides researchers with greater insights into complex biological systems by enabling simultaneous molecular and anatomical non-invasive imaging in animal models.
  • PinAAcle 900T Atomic Absorption Spectrometer

    PinAAcle 900H Atomic Absorption Spectrometer

    For laboratories needing a high-performance atomic absorption (AA) spectrometer, the PinAAcle 900H is a combined flame/furnace system with continuum source background correction.

    Because different laboratories have different needs, we provide a full suite of powerful software tools for the PinAAcle 900H, starting with the innovative and easy-to-use Syngistix for AA Express, the more comprehensive Syngistix for AA standard software, or you can add on the special Syngistix Enhanced Security option that fulfills the special needs of highly regulated laboratories, such as those operating under the rules of 21 CFR Part 11.

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