PerkinElmer

Impurity Analysis

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Comply with USP <232>/<233> and ICH Q3D regulations. 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.

For impurity analysis workflows not requiring USP <232>/<233> and ICH Q3D compliance, our portfolio of microfluidic capillary electrophoresis tools for impurity quantitation and analysis are 21 CFR 11 compatible for QC and manufacturing workflows. This automated technology requires a fraction of the sample needed for traditional CE analysis and reports results in under two minutes.

For research use only. Not for use in diagnostic procedures.

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.

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Product Type
  • Accessories (1)
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  • Software and Informatics (1)
Concentration
  • 1 µg/mL (1)
  • 100 µg/mL (2)
  • 1100 µg/mL (1)
  • 200 µg/mL (1)
  • 50 µg/mL (1)
Depth
  • 30.0 cm (1)
  • 41.0 cm (2)
  • 63.5 cm (1)
  • 69.0 cm (2)
Format
  • Microfluidics (2)
Grade
  • Pure Plus (2)
Model Compatible With
  • Labchip DropletQuant NNA (2)
Number of Elements
  • Multiple (8)
  • Single (1)
Number of Wells
  • 16 (1)
  • 96 (1)
Product Brand Name
  • DropletQuant / LabChip DS (2)
  • FIAS (1)
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  • Titan (1)
Product Group
  • Inorganic (2)
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Sample Type
  • Protein (2)
Standard Type
  • USP/ICH Standards (15)
Technology
  • Atomic Absorption (3)
  • ICP Mass Spectrometry (1)
  • Infrared (IR) (1)
  • Mercury Analysis Systems (2)
Technology Type
  • ICP Mass Spectrometry (1)
Volume Capacity
  • 125 mL (14)

"Impurity Analysis" 1-27 of 27 Products and Services

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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 FT-NIR Spectrometer

Spectrum Two N FT-NIR Spectrometer

The Spectrum Two N is a high-performance, yet robust and transportable FT-NIR system platform enabling simple, reliable NIR analyses. It’s the perfect system for labs that need to combine high-end performance with the ease-of-use features of a portable instrument, allowing users with different levels of expertise, from novice to seasoned professionals, to be proficient with it in no time.
NexION 2000 ICP-MS

NexION 2000 ICP Mass Spectrometer

PerkinElmer’s NexION® 2000 is the most versatile ICP-MS on the market, featuring an array of unique technologies that combine to deliver the highest performance no matter what your analytical challenge. Discover the effortless versatility of an instrument that makes it easy to handle any sample matrix, any interference, and any particle size.

PerkinElmer received on April 11, 2018 the Application Award from LaborPraxis in the category Bio and Pharma Analysis for the NexION 2000 ICP-MS. We were awarded this prize during analytica 2018 in Munich, Germany, in acknowledgment of a new technique enabling users to quantify the amount of metal in an individual cell for the first time.
PinAAcle 900T Atomic Absorption Spectrometer

PinAAcle 900Z Atomic Absorption Spectrometer

For laboratories needing a high-performance furnace-only atomic absorption (AA) spectrometer, the PinAAcle 900Z is a longitudinal Zeeman system with a true double-beam design for fast start-up and exceptional long-term stability.
PinAAcle 900T Atomic Absorption Spectrometer

PinAAcle 900T Atomic Absorption Spectrometer

For laboratories needing the best in both flame and THGA furnace atomic absorption (AA), the PinAAcle 900T is a combined flame/longitudinal Zeeman furnace system.
PinAAcle 900T Atomic Absorption Spectrometer

PinAAcle 900H Atomic Absorption Spectrometer

For laboratories needing a high-performance atomic absorption (AA) spectrometer, the PinAAcle 900H is a combined flame/furnace system with continuum source background correction.

Because different laboratories have different needs, we provide a full suite of powerful software tools for the PinAAcle 900H, starting with the innovative and easy-to-use Syngistix for AA Express, the more comprehensive Syngistix for AA standard software, or you can add on the special Syngistix Enhanced Security option that fulfills the special needs of highly regulated laboratories, such as those operating under the rules of 21 CFR Part 11.

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 ICP Mass Spectrometer

The NexION® 1000 ICP-MS is the ideal high-throughput system for routine, multi-elemental, trace-level analyses that meet regulatory standards – and that works within your budget. It features a host of proprietary technologies that combine to deliver exceptional speed and operational simplicity, making your lab more efficient than ever before.
PerkinElmer

USP/ICH Class 3 Elements - Parenteral PDEs

Parenteral PDE class 3 standard for USP and ICH applications.
List Price : 216.00 GBP
PerkinElmer

USP/ICH Class 3 Elements - Inhalational PDEs

Inhalational PDE class 3 standard for USP and ICH applications.
List Price : 210.00 GBP
Droplate for LabChip

DropletQuant / LabChip DS DropPlate16-D+ Chips

DropPlate16-D+ Chips, Box of 30 dual-path length chamber chips. Each chip can perform up to 16 sample reads.
List Price : 119.00 GBP
PerkinElmer

USP/ICH Class 1 Elements + TI - Inhalational PDE

Inhalational PDE class 1 elements + TI standard for USP and ICH applications.
List Price : 171.00 GBP
Droplate for LabChip

DropletQuant / LabChip DS DropPlate96-D+ Plates

DropPlate96-D+ Plate, 40 x 96 dual-path length chamber sample read plates.
List Price : 780.00 GBP
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.
List Price : 97.00 GBP
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.
List Price : 202.00 GBP
PerkinElmer

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

PDE class 2B precious metal standard for USP and ICH applications.
List Price : 276.00 GBP
PerkinElmer

USP/ICH Class 1 Elements + TL - Oral PDE

Oral PDE standard for class 1 Elements + TL for USP and ICH applications.
List Price : 172.00 GBP
PerkinElmer

USP/ICH Class 1 Elements + TI - Parenteral PDE

Parenteral PDE class 1 elemements + TI standard for USP and ICH applications.
List Price : 172.00 GBP
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Oral PDEs

Oral PDE impurities standards kit for USP and ICH applications.
List Price : 1150.00 GBP
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Inhalational PDEs

Inhalational PDE impurities standards kit for USP and ICH applications.
List Price : 1110.00 GBP
PerkinElmer

USP/ICH Elemental Impurities Standards Kit - Parenteral PDEs:

Parenteral elemental impurities standards kit for USP and ICH applications.
List Price : 1170.00 GBP
PerkinElmer

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

Parenteral PDE class 2B standard for USP and ICH applications.
List Price : 126.00 GBP
PerkinElmer

USP/ICH Class 3 Elements - Oral PDEs

Oral PDE standard for class 3 elements for USP and ICH applications.
List Price : 243.00 GBP
PerkinElmer

USP/ICH Internal Standards - All PDEs

PDE internal standard for USP and ICH applications.
List Price : 158.00 GBP
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.
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.

"Impurity Analysis" 1-27 of 27 Products and Services