Elemental Impurities Testing Solutions for Pharmaceuticals | PerkinElmer

Elemental Impurities Testing

Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in the components of the drug product, or even intentionally through residual catalysts added in synthesis. However they got there, the levels of impurities need to be controlled or they can have a negative impact on your final drug product.

In developing controls for elemental impurities in drug products, the principles of quality risk management, described in ICH Q8 and Q9 guidelines, should be considered. The risk assessment should be based on scientific knowledge and is critical to your success.

The ICH Q3D guideline for finished drug products is divided into three parts:

  • The evaluation of the toxicity data for potential elemental impurities
  • The establishment of a permitted daily exposure (PDE) for each element of toxicological concern
  • The application of a risk-based approach to control elemental impurities in drug products

That means you need the right techniques and tools to help you maintain compliance. 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.

Software Compliance

Our Syngistix atomic spectroscopy software platform, the industry’s first cross-platform instrument control solution, allows lab professionals to work seamlessly across multiple techniques, enhancing laboratory productivity. Plus, its unique icon-based design simplifies navigation and walks you through every step of the analysis — from setting up to acquiring data to reporting results. Now an Enhanced Security version is available that meets the special needs of highly regulated labs that must comply with the U.S. FDA’s 21 CFR Part 11 regulations and EU GMP Annex 11 compliance.

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NexION 2000 P ICP Mass Spectrometer Instrument

With our patented ion optic design (Triple Cone Interface and Quadrupole Ion Deflector), there’s no maintenance of components within the vacuum region, maximizing system uptime and lowering operating costs.

  • Powerful built-in All Matrix Solution (AMS) allows samples to be run with high total dissolved solids (TDS), without manual dilution, increasing the matrix tolerance for high TDS.
  • Universal Cell Technology can operate in three different modes, offering additional interference-removal techniques for your samples.
  • Syngistix for ICP-MS Enhanced Security Software delivers 21 CFR Part 11 compliance.

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Avio 500 ICP-OES Instrument

Patented Flat Plate plasma technology utilizes maintenance-free induction plates and consumes half the argon of helical coil systems, dramatically reducing operating costs.

  • Advanced optical system simultaneously collects data on more than 73 elements (UV and visible wavelengths) in a matter of seconds for exceptional sample throughput.
  • Built-in PlasmaCam camera offers continuous viewing of the plasma, simplifying method development and enabling remote diagnostic capabilities for maximum uptime.
  • Syngistix for ICP Enhanced Security Software delivers 21 CFR Part 11 compliance.

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Avio 200 ICP-OES Instrument

The smallest ICP on the market, the Avio 200 offers efficient operation, reliable data, and low cost of ownership by delivering:

  • The lowest argon consumption of any ICP: only 9 L/min, compared to 21 L/min required by other systems
  • The fastest ICP startup: spectrometer ready in just 10 minutes from power on
  • Superior sensitivity and resolution for all elements of interest
  • Extended linear range

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PinAAcle 900T Atomic Absorption Spectrometer Instrument

Transversely Heated Graphite Atomizer (THGA) and longitudinal Zeeman background correction provide superior sensitivity for complex matrices.

  • High-light-throughput optical system, combined with a solid-state detector, provides highest quality efficiency and signal-to-noise performance of any AA system on the market.
  • Cutting-edge fiber optics improve detection limits.
  • TubeView color furnace camera enables easier autosampler tip alignment and sample dispensing, and monitors drying and pyrolysis during analysis for simpler method development.
  • Syngistix for AA Enhanced Security Software delivers 21 CFR Part 11 compliance.

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Titan MPS Microwave Sample Preparation System

Top-loading system with an interlocked lid allows easy loading and removal of individual vessels.

  • Cylindrical, pressure-resistant, PFA-coated stainless-steel oven chamber and optical temperature and pressure reaction monitoring systems ensure the most reproducible results.
  • Color touchscreen controller simplifies programming, data storage, and reaction control.
  • Vessels are reusable and guaranteed for one year, for considerable savings on consumables.
  • Integrated gas collection system efficiently vents the oven chamber to keep it free of gas or acidic vapors.

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Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.

We test and validate our complete portfolio of solutions to ensure that you receive accurate, repeatable results, on time, every time, throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.

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The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.

OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.

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