Impurity Analysis

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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)

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.

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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"Impurity Analysis" 1-34 of 34 Products and Services

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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 System

The FIMS 400 is a compact, easy-to-operate mercury analyzer, featuring: two independently controlled peristaltic pumps for carrier, reagent and sample transport, delivering greater flexibility when used with optional accessories; a 5-port flow injection switching valve; and other high-quality flow injection components.

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

Optima 8300 ICP-OES Spectrometer

The Optima™ 8300 is a bench-top, dual-view ICP-OES with two solid-state SCD detectors, delivering superior detection limits and true simultaneous measurements.

LABCHIP-DS, SPECTROPHOTOMETER 96, WITH B

The first μL microplate reader giving full spectrum scans of 96 samples in under 6 minutes. The combination of the patented DropSense 96 and DropPlate 16/96 can measure up to 96 samples simultaneously from a sample volume as low as 1 μl.

LabChip GXII Touch 24

The LabChip® GXII Touch 24 system provides protein sizing and quantitation abilities to labs running smaller batch sizes of samples. Leveraging microfluidics technology, the LabChip GXII Touch 24 eliminates the need to handle time consuming SDS page gels, and provides superior results for less time and money. Assays for protein purity, glycan profiling, as well as charge heterogeneity can all be run on this single platform.

FIAS 100 Flow Injection for Atomic Spectroscopy System

The FIAS 100 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.

PinAAcle 900H Atomic Absorption Spectrometer

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

FIMS400Angle_320px

FIMS 100 Flow Injection Mercury System

The FIMS 100 is a compact, easy-to-operate mercury analyzer, featuring: one independently controlled peristaltic pump for carrier, reagent and sample transport; a 5-port flow injection switching valve; and other high-quality flow injection components.

Optima 8000 ICP-OES Spectrometer

The Optima™ 8000 is a bench-top, dual-view ICP-OES with full-wavelength-range CCD array detector, delivering flexibility and excellent analytical performance in a market-leading spectrometer.

FIAS 400 Flow Injection for Atomic Spectroscopy System

The FIAS 400 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.

LabChip_GX_GXII_Touch_Product.jpg

LabChip GXII Touch HT

The LabChip® GXII Touch system is a complete solution for consistent and precise analysis of protein samples. Leveraging microfluidics technology, the LabChip GXII Touch HT eliminates the need to handle time consuming SDS page gels, and provides superior results for less time and money.

NexION 350D ICP-MS Spectrometer

The NexION® 350D ICP-MS features a dual-channel Universal Cell and the ability to use Dynamic Reaction Cell™ technology.

NexION 350X ICP-MS Spectrometer

The NexION® 350X ICP-MS, with a single-channel Universal Cell, is well suited for general purpose applications that may be susceptible to interferences or analyses where you simply want to remove any unknown interferences.

Protein Low Molecular Weight Assay Reagent Kit

The PerkinElmer LabChip Low Molecular Weight Protein assay provides a fast and easy way to analyze protein samples between 5-80 kDa

List Price: 298.00 USD

Glycan Profiling Assay Reagent Kit

The Glycan Screening Reagent Kit is designed for the LabChip GXII, LabChip GXII Touch HT and LabChip GXII Touch 24 microfluidic systems. It provides a fast, economically efficient means to assess the main glycoforms of IgG and related proteins.

List Price: 386.00 USD

Protein Pico Assay Reagent Kit

The PerkinElmer LabChip Pico Protein reagent provides a fast and easy way to analyze protein samples between 14-200 kDa requiring sensitivity equivalent to Silver Stain levels. Protein detection for concentrations as low as 10 pg/ul, with a linear dynamic range of four orders of magnitude. Reagent designed for 400 sample capacity. Protein Express LabChip is sold separately (P/N 760499, LabChip GXII and LabChip GXII touch HT); (P/N CLS138950 for LabChip GXII Touch 24).

List Price: 1419.00 USD

Protein Express Assay 25mL Sample Buffer (bulk)

1 - 25 mL of bulk buffer for the LabChip GXII and LabChip GXII Touch HT Protein Express LabChip assay.

List Price: 55.00 USD
List Price: 704.00 USD
List Price: 366.00 USD

Protein Pico Assay 25mL Sample Buffer (bulk)

Bulk Pico Protein Sample Buffer. Quantity: 1 x 25 mL bottles

List Price: 52.00 USD
List Price: 1473.00 USD

DNA 5K / RNA / Charge Variant Assay LabChip (bulk value 4 pack)

The reusable single sipper chips allow the LabChip GX/GXII to aspirate samples directly from microplates.

List Price: 2427.00 USD

High Resolution LabChip - Protein Glycan / Low Molecular Weight Assay

LabChip® HTHigh Resolution Chip is designed for ProfilerPro® Glycan Screening in the LabChip® GXII microfluidic separations system.

List Price: 965.00 USD

LabChip DS DropPlate16-D+ Chips

TheDropPlate 16 D+ is a microfluidic disposable allowing measurement of absorbance in 2 super-positioned measuring cells with fixed pathlengths.

List Price: 183.00 USD
List Price: 192.00 USD
List Price: 3966.00 USD

Protein Express Assay LabChip (bulk value 4 pack)

The LabChip® HT Protein Express Chip is designed for the LabChip® GXII electrophoresis system. This chip will also function as a Pico Protein Chip for the same system.

List Price: 1930.00 USD

DNA 5K / RNA / Charge Variant Assay LabChip

The reusable single sipper chips allow the LabChip GX/GXII to aspirate samples directly from microplates.

List Price: 924.00 USD

Glycan Profiling Assay Release and Labeling Kit

ProfilerPro® Glycan Profiling Kit designed for the LabChip GXII microfluidic system provides a fast, economically efficient means to assess the main glycoforms of IgG and related proteins.

List Price: 1298.00 USD

Protein Express Assay LabChip

The LabChip® HT Protein Express Chip is designed for the LabChip® GXII electrophoresis system. This chip will also function as a Pico Protein Chip for the same system. This chip is available in a single pack and an economy 4-pack.

List Price: 667.00 USD

Titan MPS 8 Position Microwave Sample Preparation System

The Titan MPS 8 Position Microwave Sample Preparation System Incorporates long-life High Pressure 100mL (100 Bar) TFM digestion vessels, DTC Direct Temperature Control and DPC Direct Pressure Control for precise reaction control, and a friendly integrated color touch screen controller. For 230 Volt 50/60 Hz operation.

"Impurity Analysis" 1-34 of 34 Products and Services