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,。⮰

Business Insights (19)
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1-12 の 19 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

    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.

  • 应用文献

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

    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. 3 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.

  • 应用文献

    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).

  • 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

    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.

  • 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 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.

  • 应用文献

    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.

  • 应用文献

    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.

  • 应用文献

    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.

  • 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

    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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