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Extractables and Leachables

extractables and leachablesThe qualified team at Eutech Scientific Services possess years of experience with extractables and leachables services. EuTech has been serving the pharmaceutical and medical device industries for over to decades in analyzing their container closure systems. The issues related to extractables and leachables has always been a great challenge in the food and pharmaceutical industries wherein safety becomes a primary concern with the use of glass, plastic and rubber in a number of packaging materials.We perform these extractables and leachables studies on both organic and inorganic materials and volatile and non-volatile materials and provide qualitative and quantitative data to determine the effects of these components. Our experienced team at Eutech Scientific Services will assist in every aspect of the project from the initial stages of planning to its execution. We follow PQRI guidelines and make use of ELSIE database.

EuTech Scientific Services is a recognized support laboratory for many pharmaceutical companies. Work is conducted in our state-of-the-art facilities. We adhere to GLP guidelines of FDA. Our team of highly experienced scientists will work hand-in-hand with you to meet your analytical needs. All work is performed under strict confidentiality.

Our extractable and leachable services include the following:

Compendial Testing

  • USP/NF/EP/JP
  • USP <661> Containers
  • USP <671> Permeation
  • USP <381> Elastomeric Closures
  • HDPE, LDPE, PP, PET, PETG and Glass

Method Development and Validation

  • Identification of extractables using GC,HPLC,CE,  ICP-MS, GC-MS/MS, LC-MS/MS
  • Transfer Protocols
  • Residual Solvents (GC, GC/MS, Headspace)

Stability Testing

  • Storage in Controlled Conditions
  • Accelerated and Real Time Leachables Testing
  • Degradation Kinetics
  • Shelf Life
  • Identification of Degradation Products
  • Photolysis

Chemical Characterization

  • Identification using LC-MS/MS, GC-MS/MS, ICP-MS, NMR, Ion Chromatography
  • X-Ray Single Crystal Analysis
  • Powder Diffraction
  • DSC Analysis
  • Comparison of Extractables and Leachables Data to identify their source
  • Determination of Analytical Estimation Threshold (AET)

Additional Extractables and Leachables Testing Include:

  • Raw Material Characterization
  • Formulation Compatibility
  • Quality Control Criteria in Investigational Projects
  • Product Integrity
  • Development of Customized Protocols