PerkinElmer

杂质分析

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确保符合USP <232>/<233>幸运8平台彩票和ICH Q3D要求(该标准制药监管政策有史以来最重大的修订)。

我们提供从样品制备、仪器检测的完整解决方案,确保完全符合USP <232> / <233>和ICH Q3D中的相关规定。

样品制备

元素杂质规定概述了三种样品制备方法:

  • 将样品溶解在水中
  • 溶解在有机溶剂中
  • 封闭容器中消解(确保挥发性汞的准确测量)

幸运8平台彩票JANUS® G3 BioTX Pro和Pro-Plus工作站能够自动完成样品制备过程中繁琐且耗时的液体处理步骤。这些平台与消耗品无关,意味着它们可以适应多种净化模式。直观灵活的WinPREP®软件操作方便,能够运行您的自定义方法,并将其无缝集成到您现有的LIMS中。通过Plate Shuttle工具,在特定板孔内自动进行分配和分馏,实现真正的无人值守功能,将资源投入到无法实现自动化的流程中。

我们的产品可以为三者提供解决方案。对于需要封闭容器酸消解的不溶性样品,我们的Titan MPS™系统是最佳的解决方案。

自动采样

对于USP <233>流程自动化,我们的NexION®350 ICP-MS和Optima®8x00ICP-OES系统可与prepFAST智能采样系统兼容。与prepFAST连接后,我们的高性能ICP-MS 或 ICP-OES系统在稳定性、重复性、耐用性和精确度方面均高于所有USP<233>验证标准要求。

测量

通过使用我们行业领先的仪器,可确保符合USP和ICH法规要求。我们的 NexION® 350X电感耦合等离子体质谱仪非常适合用于元素杂质测试。设置简单、正常运行时间长且性能优越,确保您的实验室能够轻松符合USP <232> / <233>幸运8平台彩票和ICH Q3D要求。

适当情况下,ICH和USP允许使用电感耦合等离子体发射光谱技术。Optima®8x00系列是世界上应用最广的电感耦合等离子体发射光谱仪,其通过一系列尖端技术提供了突破性的性能,提高等离子稳定性、简化方法开发并大幅度降低了运营成本。

幸运8平台彩票我们还提供可备选的原子光谱技术,如火焰或石墨炉原子吸收。这些仪器只要符合USP和ICH章节中对准确性、特异性、精确度、重复性以及其他性能因素的规定要求,即可使用。

定量及尺寸

分辨率在制造和质控设置中非常重要。LabChip®GXIITouch™自动毛细管电泳平台上的Protein Clear™ 试验可在数分钟内提供高分辨率的相对杂质浓度。21 CFR 11兼容软件可确保数字记录和审计记录符合法规要求。

Protein Clear试验设计用于提取14-250 kD中的生物治疗蛋白,可对非还原mAb样品中的污染进行检测,检出限可达5 ng/µL,即主峰的1%。采用的IntelliChip™试验优化技术能够自动纠正运行间芯片负载差异,提供QC工作流程中所需的重现性和数据可靠性。

幸运8平台彩票LabChip GXII Touchpingtai采用微流控技术,将样品进样量降低至2µL,并能够在120秒内实现总样品分离,工作效率大幅高于传统CE法和SDS-PAGE凝胶法。

数据分析

幸运8平台彩票使用新型USP/ICH工具包,助您轻松满足限值和流程要求。工具包中包含:

  • 标准制备和方法开发辅助工具
  • 方法验证报告工具
  • 标准操作程序
  • 样品制备方法
  • NexION® 软件信息

工具包中包含一个J值计算器,用于精确计算元素杂质的目标极限(J值),简化标准制备和方法开发流程。此外,法验证报告工具能够快速计算和汇总方法验证数据,借助该工具可大幅提高工作效率。

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  • PinAAcle 900T Atomic Absorption Spectrometer

    PinAAcle 900H 原子吸收光谱仪

    PinAAcle™ 900H是一款高端的实验室用原子吸收光谱仪(AA),采用氘灯连续背景光源校正的火焰/石墨炉一体化设计。
  • NexION 2000B ICP-MS

    NexION 2000 ICP Mass Spectrometer

    PerkinElmer NexION® 2000是一款功能丰富、性能出众、应用广泛、简单易用的ICP-MS,融合多种独特先进技术,为您提供超高性能的分析体验,助您应对各种分析挑战。NexION 2000,挑战一切基体、挑战一切干扰、挑战一切颗粒。
  • FIAS-400 Flow Injection System

    FIAS Flow Injection System

    The FIAS is a fully integrated and automated flow injection mercury/hydride analysis system that provides new levels of automation and sample handling for AA, ICP and ICP-MS, dramatically increasing laboratory productivity and capability.
  • FIMS-400 Flow Injection Mercury Analyzer

    FIMS Flow Injection Mercury System

    The FIMS is a compact, easy-to-operate mercury analyzer with an integrated flow injection system for cold vapor mercury AA.
  • NexION 1000B ICP-MS

    NexION 1000 电感耦合等离子体质谱仪

    NexION® 1000 ICP-MS是一款专为高通量常规实验室打造的多元素、痕量分析仪器,它非常适合用于常规的日常分析,满足各类法规和标准的检测需求,同时在购买成本方面也能符合您的预期。一系列独有的专利技术使之具分析速度快、操作简便等优势,可以大大提高您的实验室运行效率。
  • Spectrum Two N FT-NIR Spectrometer

    Spectrum Two N FT-NIR Spectrometer

    Spectrum Two N™是一款高性能,坚固耐用的便携式傅里叶变化近红外光谱仪,它操作简单,并能提供可靠结果。该系统可以充分满足实验室对高端性能的迫切需求,同时又是方便易用的便携式仪器,实在是您的理想之选。无论是初出茅庐的新手,还是经验丰富的专业人员,都能立刻上手熟练操作。
  • PinAAcle 900T Atomic Absorption Spectrometer

    PinAAcle 900Z 原子吸收光谱仪

    PinAAcle™ 900Z是一款高性能实验室用单石墨炉原子吸收光谱仪(AA),带有纵向塞曼背景扣除系统,双光束设计,超快启动速度,超高长期稳定性。
  • PinAAcle_900T

    PinAAcle 900T 原子吸收光谱仪

    PinAAcle™ 900T是一款顶级的实验室用火焰/石墨炉原子吸收光谱仪(AA),火焰/石墨炉一体化设计,带有纵向塞曼背景扣除系统。
  • PerkinElmer

    USP/ICH Class 1 Elements + TI - Parenteral PDE

    Parenteral PDE class 1 elemements + TI standard for USP and ICH applications.
  • PerkinElmer

    USP/ICH Class 2B Se & Ag - Inhalational PDE

    Inhalational PDE class 2B standard for USP and ICH applications.
  • PerkinElmer

    USP/ICH Class 2A Elements - Inhalational PDEs

    Inhalational PDE class 2A standard for USP and ICH applications.
  • PerkinElmer

    USP/ICH Class 1 Elements + TL - Oral PDE

    Oral PDE standard for class 1 Elements + TL for USP and ICH applications.
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  • 指南

    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.

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    Accurate Sizing and Precise Counting of 10 nm Gold Nanoparticles using the NexION 2000 ICP-MS

    In this work, we demonstrate that PerkinElmer's NexION® 2000 ICP-MS, with its unique RF generator and ion optics, coupled with the Syngistix™ Nano Application Software Module, can be used to accurately measure and characterize NP sizes of 10 nm and smaller, both alone and in a mixture of NPs of various sizes.

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    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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    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.

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    Verification of Pharmaceutical Raw Materials using the Spectrum Two N FT-NIR Spectrometer

    Near-infrared (NIR) spectroscopy is an important technique for materials checking at various stages of the manufacturing process, but is particularly useful at the raw materials inspection stage. Raw materials come in a variety of physical forms including liquids, gels, and solids, requiring a versatile instrument with convenient, interchangeable sampling modules to cater to the entire range of raw materials encountered.

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    Analysis of Drinking and Natural Waters using the NexION 2000 ICP-MS

    幸运8平台彩票This work has demonstrated the ability of the NexION 2000 ICP-MS to analyze both natural and drinking water samples in Standard (i.e. non-cell) mode, in accordance with U.S. EPA Method 200.8. Accuracy has been demonstrated through the analysis of several reference materials and spike recoveries, with stability of at least nine hours. Method detection limits allow for trace-level determinations, while the ability to selectively suppress user-defined isotopes also allows the measurement of analyte levels usually only possible by ICP-OES or Flame AA. The NexION 2000 provides a comprehensive solution to the challenge of U.S. EPA Method 200.8 and other drinking and natural water analytical requirements across the globe.

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    Determination of Lead and Cadmium in Foods by Graphite Furnace Atomic Absorption Spectroscopy

    A major challenge in the analysis of food samples is the extremely low analyte levels and the very high matrix levels. For many years, graphite furnace atomic absorption spectroscopy (GFAAS) has been a reliable technique and the preferred method for this analysis, especially for the determination of Cd and Pb. This work will focus on the use of GFAAS for the determination of lead and cadmium in a variety of food samples.

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    Analysis of Soils and Waters in Accordance with U.S. EPA Method 6020B using the NexION 2000 ICP-MS

    Through the years, both industry and analytical instrumentation have advanced. With the development of new chemicals and processes, new pollutants may enter the environment. However, the capabilities of analytical instruments have also increased, allowing the measurement of ever lower levels of environmental contaminants, as well as new pollutants.

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    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.

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    Fast Digestion Analysis of Lead and Cadmium in Rice Using Graphite Furnace Atomic Absorption

    幸运8平台彩票Lead (Pb) and cadmium (Cd) are common pollutants in grains and are extremely toxic. Pb is harmful to human organs even at trace levels, and once it accumulates in the body, it causes inhibition of hemoglobin formation and neurological disorders. Cd is even classified as human carcinogen [Group 1 - according to International Agency for Research on Cancer]. It is reported that Cd leads to severe kidney problems which can be fatal and is also associated with brittle bones and liver problems. Rice, as the most widely consumed cereal grain in Asia/China, can quickly pick up Pb and Cd from toxins, pesticides and fertilizers in the soil, thereby endangering the health of millions of people through their diet. Therefore, it is extremely important to develop a simple, reliable method to monitor the levels of Pb and Cd in rice. According to Chinese national standard GB 2715-2016 Hygienic Standard for Grain, the maximum concentrations of Pb or Cd in grains must be below 0.2 mg/kg; the allowable level in the European Union is the same [EC 1881/2006]. The official technique for the determination of heavy metals in both cases is graphite furnace atomic absorption spectroscopy (GFAAS, GB/T 5009. 12-2017, GB/T 5009-2017. 15 and EN 14083:2003). Samples can be pretreated using various methods, including microwave digestion, hot block digestion, dry ashing, and hot plate digestion. It is found that these conventional digestion procedures are always complicated and time-consuming (two-four hours or even longer). Plus, conventional sample preparation techniques require large quantities of corrosive and oxidizing reagents, increasing the chance for contamination which could lead to inaccurate results. Special PTFE vessels are needed for microwave digestion; however, reusable utensils might also cause cross contamination.

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    A Comparison of Two FT-NIR Sampling Techniques for SIMCA Classification of Spectroscopically Similar Pharmaceutical Raw Materials

    NIR Spectroscopy is a useful technique for raw materials identification and verification, but the sophistication of the technique might differ based on the sample. If the materials to be identified are spectroscopically dissimilar, it is often only necessary to use a simple distance measure such as a spectral difference for identification. If the spectra are similar, on the other hand, it may be necessary to use more sophisticated techniques which take into consideration both the intra- and inter-material spectral variation for identification and classification. The SIMCA (Soft Independent Modelling of Class Analogy) algorithm, a Principal Component Analysis (PCA) method, provides such an example.

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    Quantification of Nanoparticle Uptake into Cancer Cells using Single Cell ICP-MS

    幸运8平台彩票Nanoparticles (NPs) have been of significant interest over the last two decades as they offer attractive benefits for drug delivery to overcome limitations in conventional chemotherapy. Nanoparticles can be engineered to carry both drugs and imaging probes to simultaneously detect and treat cancer. They may also be designed to specifically target diseased tissues and cells in the body. A number of nanoparticlebased cancer therapeutics have been approved for clinical use and/or are currently under development.

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