PerkinElmer

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⮱确保符合USP <232>/<233>和ICH Q3D要求(该标准制药监管政策有史以来最重大の修订),。⮰

⮱我们提供从样品制备、仪器检测の完整解决方案,。确保完全符合USP <232> / <233>和ICH Q3D中の相关规定,。⮰

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(确保挥发性汞の准确测量)

⮱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の液体处理步骤,。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,。直观灵活のWinPREP®软件操作方便,。能够运行您の自定义方法,。并将其无缝集成到您现有のLIMS中,。通过Plate Shuttle工具,。在特定板孔内自动进行分配和分馏,。实现真正の无人值守功能,。将资源投入到无法实现自动化の流程中,。⮰

⮱我们の产品可以为三者提供解决方案,。对于需要封闭容器酸消解の不溶性样品,。我们のTitan MPS™系统是最佳の解决方案,。⮰

自动采样

对于USP <233>流程自动化,。我们の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,。我们の高性能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の仪器,。可确保符合USP和ICH法规要求,。我们の 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,。确保您の实验室能够轻松符合USP <232> / <233>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の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の性能,。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,。⮰

⮱我们还提供可备选の原子光谱技术,。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の规定要求,。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のProtein Clear™ 试验可在数分钟内提供高分辨率の相对杂质浓度,。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中の生物治疗蛋白,。可对非还原mAb样品中の污染进行检测,。检出限可达5 ng/µL,。即主峰の1%,。采用の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工作流程中所需の重现性和数据可靠性,。⮰

⮱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

⮱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,。万博AR彩票用于精确计算元素杂质の目标极限(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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1-12 の 32 产品与服务

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1-12 の 22 Business Insights

  • 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.

  • 应用文献

    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.

  • 应用文献

    Transport of Nanoparticles From Coated Surfaces Through Physical Contact

    This work investigated the transfer of Ag and CuO nanoparticles from consumer products via simulated dermal contact by using textile wipes as a surrogate using PerkinElmer’s NexION ICP-MS single particle analyzer with the unique Syngistix Nano Application software module for data collection and analysis

  • 应用文献

    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.

  • 应用文献

    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.

  • 应用文献

    New Research Evaluating Cisplatin Uptake in Ovarian Cancer Cells by Single Cell ICP-MS

    Cisplatin, carboplatin, and oxaliplatin are the most widely used of platinum-based cancer chemotherapy drugs in the Western world. Cisplatin's effectiveness is due to its ability to bind to the DNA, resulting in DNA-platinum (Pt) adducts, which bend the DNA. The cells must then repair the DNA damage, otherwise DNA replication is blocked resulting in cell death. Many cancers are initially sensitive to platinum-based treatment, but patients frequently relapse with tumors displaying resistance to further cisplatin therapy.

  • 应用文献

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

    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.

  • 应用文献

    Characterization of TiO2 Nanoparticle Release from Fabrics By Single Particle ICP-MS

    In the textile industry, the use of titanium dioxide (TiO2) nanoparticles (NPs) is increasing due to their ability to provide UV protection, increase the hydrophilic nature of fabrics, provide antibacterial characteristics, and reduce odors. This work studies the release of TiO2 NPs from various commercial textile products which do not advertise that TiO2 NPs have been added.

  • 应用文献

    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.

  • 应用文献

    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.

  • 应用文献

    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 has been implemented since 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.

  • 应用文献

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

    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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