PerkinElmer

杂质分析

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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)

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>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。

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。

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,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。

  • 产品与服务

  • 资源,活动及更多信息

缩小结果
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)

"杂质分析" 1-3232 产品与服务

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。
NexION 2000 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。
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.
PinAAcle 900T Atomic Absorption Spectrometer

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。
FIAS-100 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.
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 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。
Droplate for LabChip

DropletQuant/LabChip DS DropPlate16-D+芯片

DropPlate16-D+芯片,30个装双路径长度腔式芯片盒。每个芯片都可以进行最多16个样本读取。
PerkinElmer

USP/ICH Class 1 Elements + TI - Inhalational PDE

Inhalational PDE class 1 elements + TI standard for USP and ICH applications.
PerkinElmer

USP/ICH Class 3 Elements - Parenteral PDEs

Parenteral PDE class 3 standard for USP and ICH applications.
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Inhalational PDEs

Inhalational PDE impurities standards kit for USP and ICH applications.
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 Precious Metal Elements (All PDEs)

PDE class 2B precious metal standard for USP and ICH applications.
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Oral PDEs

Oral PDE impurities standards kit for USP and ICH applications.
PerkinElmer

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

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

USP/ICH Class 2B Precious Metal Elements (no Os) - All PDEs

PDE standard for class 2B precious metal elements for USP and ICH applications.
USP/ICH Class 1 Elements + TL - Oral PDE

Gold (Au) Pure Plus Single-Element Standard, 100 μg/mL, 2% HCL, 125 mL

Each of our Atomic Spectroscopy Calibration Standard is supplied with a comprehensive Certificate of Analysis that documents the quality and reliability.
Droplate for LabChip

DropletQuant/LabChip DS DropPlate96-D+微孔板

DropPlate96-D+微孔板,40 x 96双路径长度腔式样本读取微孔板。
PerkinElmer

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

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

USP/ICH Internal Standards - All PDEs

PDE internal 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 3 Elements - Inhalational PDEs

Inhalational PDE class 3 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.
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Parenteral PDEs:

Parenteral elemental impurities standards kit for USP and ICH applications.
PerkinElmer

USP/ICH Class 3 Elements - Oral PDEs

Oral PDE standard for class 3 elements for USP and ICH applications.
Titan - Closed - Front View

Titan MPS Microwave Sample Preparation System

The Titan MPS is a flexible easy-to-use microwave sample preparation system for pressure digestion of a broad range of samples for subsequent inorganic analysis.
Syngistix_for_ICPEnhancedSecurity

Syngistix for ICP Enhanced Security Software for 21 CFR Part 11 Compliance

Syngistix for ICP Enhanced Security Software is an extension of Syngistix for ICP Software for Avio® and Optima® ICP-OES spectrometers, delivering additional capabilities needed by highly regulated laboratories, such as those needing to comply with the U.S. FDA’s 21 CFR Part 11 regulations. Syngistix for ICP Enhanced Security Software (version 4.0 or higher) provides the functionality to fully meet the technical requirements for 21 CFR Part 11 compliance. Key features include: secure audit trail, electronic signatures and records, data integrity, password-protected database file structure, login history, configurable password control.
Syngistix_for_AA_EnhancedSecurity

Syngistix for AA Enhanced Security Software for 21 CFR Part 11 Compliance

Syngistix for AA Enhanced Security™ Software is an extension of Syngistix for AA Software for PinAAcle™ atomic absorption spectrometers, delivering additional capabilities needed by highly regulated laboratories, such as those needing to comply with the U.S. FDA’s 21 CFR Part 11 regulations. Syngistix for AA Enhanced Security Software (version 4.0 or higher) provides the functionality to fully meet the technical requirements for 21 CFR Part 11 compliance. Key features include: secure audit trail, password-protected access control, multilevel user permissions, electronic signatures, data integrity, and database file structure.
PC Monitor image with screen capture from product note

Syngistix for ICP-MS Automated Method Validation Application Software Module

Validation of analytical methods is a requirement for many types of labs and method validation is a critical step as these labs seek to obtain accreditation. The challenge is in satisfying regulatory compliance while significantly improving data traceability.

Manual processes of validating methods are time-consuming and prone to errors, which negatively impacts productivity. The Syngistix Automated Method Validation application module, an extension of our Syngistix for ICP-MS software and NexION® ICP-MS instruments, is designed to eliminate process inefficiencies by streamlining the workflow and avoiding potential human error faced in traditional ICP-MS method validation.

Clarity-Software

Clarity Chromatography Software for Speciation Analyses

Clarity chromatography software (version 8.1 or higher) is part of PerkinElmer’s NexSAR HPLC-ICP-MS Speciation Analysis Ready Solution, which couples the NexSAR HPLC to the NexION® ICP-MS in a seamless and integrated platform.

It allows streamlined workflows, from method development through to reporting. Data processing, integration and calibration are straightforward, and for the most discerning users, advanced integration features are also available. Reporting is simple, allowing you to export the data in a number of different formats and personalize your reporting style to suit your individual needs.

"杂质分析" 1-3232 产品与服务