, USP <233>, ICH Q3D, elemental impurities analysis, pharmacuetical drug testing">
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Ensure compliance with USP <232>/<233> and ICH Q3D, which are among the most significant changes in pharmaceutical regulatory policy ever.

From sample preparation and instrumentation to our comprehensive toolkit, we offer complete, integrated solutions to ensure your work fully adheres to the guidelines set out in USP <232>/<233> and ICH Q3D.

Sample Preparation

Elemental impurities regulations outline three types of sample preparation:

  • Sample dissolution in water
  • Dissolution in organic solvent
  • Closed vessel digestion (to ensure accurate measurement of volatile Hg)

The JANUS? G3 BioTX Pro and Pro-Plus workstations automate the tedious and time consuming liquid handling steps of sample preparation. These platforms are consumable-agnostic, meaning they can accommodate multiple modes of purification. The intuitive and flexible WinPREP? software is easy to use yet capable of running your custom protocols and integrating seamlessly into your existing LIMS. Automate dispensing and fractionation within specific wells with the Plate Shuttle tool to create true, walk-away capabilities which allow you to dedicate your resources to processes that can’t be automated.?

Through our portfolio, we offer solutions for all three. For insoluble samples that require closed-vessel acid digestion, our Titan MPS? system is the ideal solution.

Autosampling

?

For automating the USP <233> process, our NexION? 350 ICP-MS and Optima? 8x00 ICP-OES systems can be coupled with the prepFAST intelligent sampling system. When coupled with the prepFAST, our high-performing ICP-MS or ICP-OES systems exceed all USP <233> validation criteria for stability, repeatability, ruggedness, and accuracy.

Measurement

With our industry leading instrumentation, you will be complying with USP and ICH regulations in no time. Our NexION? 350X ICP-MS is perfectly suited for implementing elemental impurities testing. With easy setup, increased uptime, and superior performance, your lab can comfortably implement and comply with USP <232>/<233> and ICH Q3D.

Where appropriate, ICH and USP allows for the use of ICP-OES technology. The world’s most popular ICP-OES, the Optima? 8x00 series, delivers breakthrough performance using a series of cutting-edge technologies that enhance plasma stability, simplify method development, and dramatically reduce operating costs.

We also offer alternative atomic spectroscopic techniques, such as flame or graphite atomic absorption. These instruments can be used provided they meet USP and ICH’s stringent requirements for accuracy, specificity, precision, repeatability, and other performance factors detailed in USP and ICH chapters.

Quantitation and Sizing

Resolution matters in manufacturing and QC settings. The Protein Clear? assay on the LabChip? GXII Touch? automated capillary electrophoresis platform provides high resolution relative impurity concentrations in minutes. 21 CFR 11 compatible software ensures that digital records and audit trails comply with regulatory requirements.

The Protein Clear assay? is designed for biotherapeutic proteins from 14-250 kD and can detect contamination in non-reduced mAb samples with a limit of detection of 5 ng/μL, or 1% of the main peak. The incorporated IntelliChip? assay optimization technology automatically corrects for inter-run chip loading differences, providing the reproducibility and data confidence your QC workflow requires.

The LabChip GXII Touch platform uses microfluidic technology that reduces sample requirements to just 2 μL, and achieves total sample separation? in under 120 seconds, significantly faster than traditional CE methods and SDS-PAGE gels.

Data Analysis

With the new USP/ICH Toolkit, you can rest assured that complying with these limits and procedures will be easier than ever. The Toolkit provides:

  • Tools to assist with standard preparation and method development
  • Method validation reporting tool
  • Standard Operating Procedures (SOP)
  • Sample preparation methods
  • NexION? software information

The Toolkit includes a J Value Calculator for accurate calculations of Target Limits (J values) of elemental impurities, making standard preparation and method development easier. It also helps improve efficiencies with the Method Validation Report Tool, which calculates and summarizes method validation data instantly.

  • 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)
  • 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
  • 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)
  • ICP Mass Spectrometry (1)
技术类型
  • Infrared (1)
体积容量
  • 125 mL (16)

"杂质分析" 1-2828 产品与服务

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。
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.
Spectrum Two N NIRM

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 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。
NexION 1000 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。

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。
FIAS-400 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 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。
PerkinElmer

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

Inhalational PDE class 2B 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 3 Elements - Parenteral PDEs

Parenteral PDE class 3 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 2B Precious Metal Elements (no Os) - All PDEs

PDE standard for class 2B precious metal elements 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

Osmium (Os) Pure Plus Single-Element Standard, 100 μg/mL, 15% HCl, 125 mL

Single element, 125 mL Pure Plus aqueous inorganic standard
PerkinElmer

USP/ICH Class 2B Precious Metal Elements (All PDEs)

PDE class 2B precious metal standard 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 2A Elements - Inhalational PDEs

Inhalational PDE class 2A 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.
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 3 Elements - Inhalational PDEs

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

USP/ICH Class 1 Elements + TI - Inhalational PDE

Inhalational PDE class 1 elements + TI standard for USP and ICH applications.
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 3 Elements - Oral PDEs

Oral PDE standard for class 3 elements 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 Elemental Impurities Standards Kit - Oral PDEs

Oral PDE impurities standards kit 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.

"杂质分析" 1-2828 产品与服务

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