辽宁11选5官方网站|辽宁11选5基本走势图手机版下载|
PerkinElmer

杂质分析

OF

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的修订)。

我们提供从样?#20998;?#22791;、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?#20998;?#22791;

元素杂质规定概述了三种样?#20998;?#22791;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)

JANUS? G3 BioTX Pro和Pro-Plus工作站能够自动完成样?#20998;?#22791;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?#24535;?#21270;模?#20581;?#30452;观灵活的WinPREP?软件操作方便,能够运?#24515;?#30340;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?#35797;?#25237;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。?#26434;?#38656;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

?#26434;赨SP <233>流?#22871;?#21160;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?#30830;?#38754;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>和ICH Q3D要求。

适当情况下,ICH和USP?#24066;?#20351;用电感耦合等离子体发射光?#20934;?#26415;。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?#26723;?#20102;运营成本。

我们还提供可备选的原子光?#20934;?#26415;,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?#21462;?#37325;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?#35797;?#21046;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?#21462;?1 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?#20998;?#30340;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?#20013;?#21644;数据可靠性。

LabChip GXII Touchpingtai采用微流控技术,将样品进样量?#26723;?#33267;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?#20998;?#22791;方法
  • NexION? 软件信息

工具包中包含一个J?#23548;?#31639;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。

Business Insights (17)
Filters:

Filters :

資源庫
  • Application Note (15)
  • Guide (1)
  • Flyer (1)

1-12 的 17 Business Insights

  • 指南

    Guide to Herb & Spice Adulteration Screening Using NIR

    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. NIR spectroscopy used with the method outlined here can provide a rapid screening technique for detecting adulteration in herbs and spices.

  • 应用文献

    Analysis of Single-Walled Carbon Nanotubes with SP-ICP-MS

    Measuring the amount of metals in CNTs presents a challenge. High levels can be measured directly in the solid by several techniques, including XRF and TEM, while low-level analysis requires complete digestion of the sample prior to analysis by ICP-OES or ICP-MS.

  • 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

    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

    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

    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

    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

    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

    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

    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

    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

    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.

  • Jump to:
产品与服务 (32)
Filters:

Filters :

产品类型
  • Consumables (19)
  • Instruments (8)
  • Software and Informatics (4)
  • Accessories (1)
浓度
  • 100 μg/mL (2)
  • 1 μg/mL (1)
  • 50 μg/mL (1)
  • 200 μg/mL (1)
  • 1100 μg/mL (1)
深度
  • 41.0 cm (2)
  • 69.0 cm (2)
  • 30.0 cm (1)
  • 63.5 cm (1)
格式
  • Microfluidics (2)
级别
  • Pure Plus (2)
型号兼容
  • Labchip DropletQuant NNA (2)
Number of Elements
  • Multiple (8)
  • Single (1)
产品品牌名称
  • PinAAcle (3)
  • DropletQuant / LabChip DS (2)
  • NexION (2)
  • Titan (1)
  • FIAS (1)
  • FIMS (1)
  • Spectrum Two N (1)
产品组
  • Software and Informatics (3)
  • Inorganic (2)
  • Instrument (1)
样品类型
  • Protein (2)
标准型
  • USP/ICH Standards (17)
技术
  • Atomic Absorption (3)
  • Mercury Analysis Systems (2)
  • Infrared (IR) (1)
  • ICP Mass Spectrometry (1)
技术类型
  • ICP Mass Spectrometry (1)
  • Atomic Absorption (1)
  • ICP Optical Emission Spectroscopy (1)
体积容量
  • 125 mL (16)

1-12 的 32 产品与服务

  • Jump to:
辽宁11选5官方网站
吉林十一选五走势 广东十一选五软件下 上海快上海快3 专家4场进球彩 中国足球排名世界第 成都国际足球中心 什么叫配资 最好的股票配资平台 股票分析师年薪 免费股票分析软件排行榜