Extractables and Leachables

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.

Contact us for the following services:

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

  • Separation Methods using GC/HPLC/CE
  • Other analytical procedures
  • Transfer Protocols

Stability Testing

  • Storage in Controlled Conditions
  • Accelerated Stability
  • Degradation Kinetics
  • Shelf Life
  • Identification of Degradation Products
  • Photolysis

Chemical Characterization

  • Identification using LC-MS/MS, GC-MS/MS, ICP-MS, NMR
  • X-Ray Single Crystal Analysis
  • Powder Diffraction
  • DSC Analysis

Miscellaneous

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