Impurity Analysis


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.


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.


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.

Business Insights (17)

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  • Guide

    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.

  • Application Note

    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.

  • Application Note

    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.

  • Application Note

    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.

  • Application Note

    Trace Metals in Waters by GFAAS, in Accordance with U.S. EPA and Health Canada Requirements

    Precise and accurate measurements at the regulated levels are an important factor for assuring safe drinking water. U.S. EPA Method 200.91 is the method cited by EPA, Health Canada, and the WHO for the use of graphite furnace atomic absorption spectroscopy (GFAAS). In evaluating a GFAAS system for determination of these elements, it must provide good sensitivity, low noise, limited drift, and accuracy in matrices with high salt content (hard water) that might be found in drinking waters. In this work, the PinAAcle™ 900T, with a unique optical system, is evaluated for the use of EPA Method 200.9 for As, Cd, Pb, Se, and Tl in drinking waters.

  • Application Note

    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.

  • Application Note

    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.

  • Application Note

    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).

  • Application Note

    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. 3 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.

  • Application Note

    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.

  • Application Note

    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.

  • Application Note

    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.

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  • NexION 2000B 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.
  • 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.
  • 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.
  • 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.

  • 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 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.
  • 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.
  • 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 - Inhalational PDEs

    Inhalational PDE class 3 standard for USP and ICH applications.
    List Price : 432.00 USD
  • 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 : 194.00 USD
  • PerkinElmer

    USP/ICH Internal Standards - All PDEs

    PDE internal standard for USP and ICH applications.
    List Price : 325.00 USD
  • PerkinElmer

    USP/ICH Class 2A Elements - Inhalational PDEs

    Inhalational PDE class 2A standard for USP and ICH applications.
    List Price : 292.00 USD
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