/<233> and ICH Q3D."> , USP <233>, ICH Q3D, elemental impurities analysis, pharmacuetical drug testing"> 十三水微信红包群 十三水群
PerkinElmer

雜質分析

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確保符合USP <232>/<233>和ICH Q3D要求(該標準制藥監管政策有史以來最重大的修訂)。

我們提供從樣品制備、儀器檢測的完整解決方案,確保完全符合USP <232> / <233>和ICH Q3D中的相關規定。

樣品制備

元素雜質規定概述了三種樣品制備方法:

  • 將樣品溶解在水中
  • 溶解在有機溶劑中
  • 封閉容器中消解(確保揮發性汞的準確測量)

JANUS? G3 BioTX Pro和Pro-Plus工作站能夠自動完成樣品制備過程中繁瑣且耗時的液體處理步驟。這些平臺與消耗品無關,意味著它們可以適應多種凈化模式。直觀靈活的WinPREP?軟件操作方便,能夠運行您的自定義方法,并將其無縫集成到您現有的LIMS中。通過Plate Shuttle工具,在特定板孔內自動進行分配和分餾,實現真正的無人值守功能,將資源投入到無法實現自動化的流程中。

我們的產品可以為三者提供解決方案。對于需要封閉容器酸消解的不溶性樣品,我們的Titan MPS?系統是最佳的解決方案。

自動采樣

對于USP <233>流程自動化,我們的NexION?350 ICP-MS和Optima?8x00ICP-OES系統可與prepFAST智能采樣系統兼容。與prepFAST連接后,我們的高性能ICP-MS 或 ICP-OES系統在穩定性、重復性、耐用性和精確度方面均高于所有USP<233>驗證標準要求。

測量

通過使用我們行業領先的儀器,可確保符合USP和ICH法規要求。我們的 NexION? 350X電感耦合等離子體質譜儀非常適合用于元素雜質測試。設置簡單、正常運行時間長且性能優越,確保您的實驗室能夠輕松符合USP <232> / <233>和ICH Q3D要求。

適當情況下,ICH和USP允許使用電感耦合等離子體發射光譜技術。Optima?8x00系列是世界上應用最廣的電感耦合等離子體發射光譜儀,其通過一系列尖端技術提供了突破性的性能,提高等離子穩定性、簡化方法開發并大幅度降低了運營成本。

我們還提供可備選的原子光譜技術,如火焰或石墨爐原子吸收。這些儀器只要符合USP和ICH章節中對準確性、特異性、精確度、重復性以及其他性能因素的規定要求,即可使用。

定量及尺寸

分辨率在制造和質控設置中非常重要。LabChip?GXIITouch?自動毛細管電泳平臺上的Protein Clear? 試驗可在數分鐘內提供高分辨率的相對雜質濃度。21 CFR 11兼容軟件可確保數字記錄和審計記錄符合法規要求。

Protein Clear試驗設計用于提取14-250 kD中的生物治療蛋白,可對非還原mAb樣品中的污染進行檢測,檢出限可達5 ng/μL,即主峰的1%。采用的IntelliChip?試驗優化技術能夠自動糾正運行間芯片負載差異,提供QC工作流程中所需的重現性和數據可靠性。

LabChip GXII Touchpingtai采用微流控技術,將樣品進樣量降低至2μL,并能夠在120秒內實現總樣品分離,工作效率大幅高于傳統CE法和SDS-PAGE凝膠法。

數據分析

使用新型USP/ICH工具包,助您輕松滿足限值和流程要求。工具包中包含:

  • 標準制備和方法開發輔助工具
  • 方法驗證報告工具
  • 標準操作程序
  • 樣品制備方法
  • NexION? 軟件信息

工具包中包含一個J值計算器,用于精確計算元素雜質的目標極限(J值),簡化標準制備和方法開發流程。此外,法驗證報告工具能夠快速計算和匯總方法驗證數據,借助該工具可大幅提高工作效率。

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1-12 的 32 產品與服務

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1-12 的 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.

  • 應用文獻

    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.

  • 應用文獻

    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.

  • 應用文獻

    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. 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.

  • 應用文獻

    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.

  • 應用文獻

    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.

  • 應用文獻

    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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    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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    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.

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    Fast Digestion Analysis of Lead and Cadmium in Rice Using GFAAS with Deuterium Background Correction

    Toxic elements, such as lead (Pb) and cadmium (Cd), are entering the food chain through environmental contamination. Rice, as the most widely consumed cereal grain in Asia, can quickly pick up Pb and Cd from soil, thereby seriously endangering human health through diet. These toxic element levels need to be carefully monitored. Maximum levels of Pb and Cd are strictly regulated in Asian countries, especially in China; therefore, it is extremely important to develop a simple, reliable method for trace levels of Pb and Cd in rice. The allowable maximum levels of Pb and Cd in grains in EU and China are required to be below 0.2 mg/kg (Commission Regulation EC 1881/2006 and Chinese GB 2715-2016 Hygienic Standard). Graphite furnace atomic absorption spectroscopy (GFAAS) is the officially recommended technique for detection of trace elements in various food stuffs (GB/T 5009.15-2017, GB/T 5009. 12-2017 and EN 14083:2003). Food samples are usually pretreated before GFAAS analysis using various methods: microwave digestion, hot block digestion, dry ashing, and hot plate digestion. These conventional digestion procedures are usually complicated and time-consuming (2-4 hours or longer). Plus, they require large quantities of corrosive and oxidizing reagents, increasing the chance for contamination which could lead to inaccurate results. However, fast digestion can effectively speed up the sample preparation procedure while reducing the use of corrosive reagents and the chance for contamination.

  • 應用文獻

    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.

  • 應用文獻

    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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