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Extractables & Leachables for Pharmaceuticals

pharma-extractables-leachables

Applicable Standards

  • EP
  • USP
  • ISO
  • ICH

Services Summary

Nelson Labs offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.

Analytical Expertise

Nelson Labs is equipped with state-of-the-art analytical technology, such as:

  • Headspace coupled to gas chromatography with mass spectral detection (HS-GC/MS)
  • Gas chromatography with a mass spectral detection (GC/MS)
  • Programmable temperature vaporizer gas chromatography with mass spectral detection (PTV-GC/MS)
  • Liquid chromatography with a diode array detection combined with mass spectral detection (HPLC-UV/MS)
  • Liquid chromatography with multiple order mass spectral detection (LC/MS/MS)
  • Inductively coupled plasma with optical emission detection (ICP-OES)
  • Ion chromatography (IC)
  • Graphite furnace – Atomic absorption spectroscopy (GF-AAS)
  • Infrared spectrophotometry (FTIR)
  • UV/VIS – Spectrophotometry
  • Total organic carbon analysis (TOC)

All instruments are dedicated to – and the methods are optimized for – extractables and leachables testing for the pharmaceutical industry, which requires all analytical equipment to be fully qualified (IQ/OQ/PQ).

In addition to standard Pharmaceutical Extractables & Leachables testing programs, Nelson Labs can offer its assistance in the elucidation of structural information for critical compounds, using GC-ToF-MS, LC/MS-Orbitrap, LC-ToF-MS, FT-MS, or NMR.

Because of the high importance of a unique identification of material impurities during extractable and leachable studies, Nelson Labs has built up a “library” of more than 1,000 reference standards, relevant to trace impurity testing in polymers and rubbers. These reference standards are used to confirm the identity (via retention time or mass spectral confirmation) of the extractable/leachable compounds.

Nelson Labs also offers capacity for storage under controlled temperature and humidity for a variety of different storage conditions to support the stability program for leachable studies. The climatic chambers are fully qualified and are monitored via a central data logging system.

Our analytical expert team has broad experience in method development and validation of a long list of trace impurities (leachables) in a variety of pharmaceutical matrices, ranging from aqueous buffered saline solutions, more complex pharmaceutical formulations (e.g., containing Polysorbate, PEG, protein solutions) and even very complex matrices (e.g., oily solutions, syrups, ointments).

Polymer Knowledge & Regulatory Guidelines

Although E&L-trace analysis testing often poses significant challenges to the analytical development team and therefore requires a high level of analytical expertise, it is of equal importance to have a thorough understanding of polymers and rubbers, together with a profound knowledge of the global regulatory requirements per type of application. This combined expertise is of high importance in both the development phase of a testing strategy for a specific E&L project, as well as to understand and interpret the obtained analytical results and to assess these data from a regulatory point of view. Nelson Labs packaging solutions department has experience with successful validations encompassing multiple product, package and sterilization configurations throughout the medical and pharmaceutical industries. We use proven state-of-the-art technology to provide fast and accurate results.

ISO 10993 Biocompatibility and E&L

E&L services are a part of a full medical device biocompatibility test program following ISO 10993. This program includes a range of tests and Toxicological Risk Assessments.

If you have additional questions about Extractables and Leachables testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.

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