Keep Extractables & Leachables Under Control | PerkinElmer

Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to guarantee the safety and quality of finished dosage forms being released to the market.

Studies about extractables and leachables are critical for maintaining the quality of your drug product during drug development and final batch release in accordance with GMP compliance. The testing process assesses whether the drug products could be exposed to any harmful leachable contaminants that could have a detrimental impact upon the safety and efficacy of the drug.

In general, extractables and leachables can be divided into three broad groups:

  • Non-volatile leachables
  • Volatile and semi volatile leachables
  • Inorganic/elemental leachables

Elemental Impurities in extractables and leachables are best determined by ICP-OES, ICP-MS, and GC-MS for volatiles whereas HPLC or UHPLC are preferable method for non-volatile compounds. We provide the tools you need to take control of your extractables and leachables testing.

NexION 2000 P

Patented ion optic design (triple cone interface and quadrupole ion deflector) delivers no maintenance of the components within the vacuum region, maximizing sample throughput 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 for 21 CFR Part 11 compliance
  • Radian remote monitoring provides real-time monitoring of your system’s diagnostic parameters, maximizing uptime

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Avio 500

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

  • Advanced optical system simultaneously collects data from 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 for 21 CFR Part 11 compliance
  • Radian remote monitoring provides real-time monitoring of your system’s diagnostic parameters, maximizing uptime

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PinAAcle 900T

Transversely heated graphite atomizer (THGA) and longitudinal Zeeman background correction provide superior sensitivity for complex matrices.

  • Highlight throughput optical system, combined with a solid-state detector, provides the highest-quality efficiency and signal-to-noise performance of any AA system on the market
  • Cutting-edge fiber optics for improved detection limits
  • TubeView color furnace camera for easier autosampler tip alignment and sample dispensing, as well as to monitor drying and pyrolysis during analysis for simpler method development
  • Syngistix for AA Enhanced Security Software for 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 touch-screen 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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Clarus SQ8 GC/MS

The Clarus® SQ 8 GC/MS offers unsurpassed sensitivity and unparalleled stability for identification and quantitation of volatile and semi-volatile compounds (VOC and SVOC). It's designed to deliver high throughput, rugged dependability, and great results. Plus, with our patented SMARTsource (for both EI and CI), maintenance is easy.

  • SMARTsource (simplified maintenance and removal technology) offers easy source (EI and CI) access and maintenance with no tools required to remove or disassemble
  • Fastest conventional GC oven available that heats up and cools down more rapidly than other ovens for unsurpassed productivity
  • The Clarify detector is the world’s most sensitive detector, delivering exceptional sensitivity by eliminating background noise and maximizing analyte signals

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TurboMatrix HS-40

The TurboMatrix HS-40 Trap features built-in analyte-trapping technology that provides a potential 100-fold increase in sensitivity. Thanks to pressure-balanced technology, TurboMatrix Headspace samplers deliver exceptional performance in the analysis of your samples. Greater sensitivity can be achieved because the system offers an array of unique features and benefits:

  • Zero dilution liner ensures sample gas flows undiluted from the transfer line into the column
  • No fractionation due to pressure and temperature changes experienced with syringe-based systems
  • Sample is introduced rapidly and as a sharp band to the GC, resulting in sharper peaks
  • Minimal number of hardware components meet the sample, keeping contamination low

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LC 300 UHPLC System

Our LC 300 UHPLC is the system of choice for applications that demand superior performance and sensitivity. With ultra-precise gradient flows up to 18,000 psi/1,240 bar, the LC 300 UHPLC system delivers the power and increased throughput required for even the most demanding applications.

Key features of the LC 300 UHPLC platform include:

  • 18,000 psi (1240 bar) autosampler and pump configuration.
  • Patented ILD injection valve design reduces pressure and shock to improve data quality and increase column lifetimes.
  • Integrated solvent containment and column oven for reduced system complexity
  • Wide range of detectors: PDA, MWD, UV/Vis, FL and RI
  • Automated sample dilution and derivatization
  • Full instrument control and data processing with the SimplicityChrom CDS software

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LC 300 HPLC System

The next generation LC 300 HPLC system delivers the accuracy and flexibility needed for routine liquid chromatography applications. With its robust feature set and intuitive operation, the LC 300 HPLC has been designed to increase your laboratory productivity and throughput, even in the face of challenging budget and staffing situations.

Key features of the LC 300 HPLC platform include:

  • 10,000 psi (690 bar) autosampler and pump configuration.
  • High visibility color display for immediate assessment of system status without having to log into your CDS software.
  • Outstanding injection reproducibility – even at low volumes
  • Three injection modes: full loop, partial fill and µL-pickup for maximum flexibility
  • Long seal life via a dedicated and automated piston seal wash mechanism
  • Wide range of detectors: PDA, MWD, UV/Vis, FL and RI

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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 invest heavily in testing and validating 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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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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