Biopharmaceutical Services

Residual Impurities

Test Articles

We offer services in support of these test articles.

Residual Impurities

Residuals Impurities are typically present at low levels in difficult sample matrices, and development and validation of assays and ongoing testing can be quite challenging. Whether you have impurities that are being introduced in upstream steps from culture growth and harvest or in the downstream processes–we provide expert testing, profiling and consultationfor Residual Impurities monitoring.

Why Choose Eurofins Lancaster Laboratories?

  • With extensive expertise in developing, validating and providing testing support for residual impurities, we can provide you with the best strategy for monitoring residual impurities and accelerating your drug development programs.
  • Our 30-year history of cGMP regulatory compliance ensures delivery of the highest quality data.

Testing Services Available

Overview of Our Experience

Residual Antibiotics

  • Kanamycin, ampicillin, penicillin, chloramphenicol, gentamicin sulfate, amphotericin B, hygromycin B, plasmocin

Surfactants & Antifoams

  • Triton-X, Pluronic, Tween 20 & 80, Antifoam A,B

Process-Enhancing Agents

  • IPTG, DTT, Urea, Guanidine

Residual Solvents

  • USP <467> and Custom Methods

Extractables & Leachables

  • Design and execution of forced extraction, controlled extraction and leaching studies

Metals

  • 34 elemental scans for ICP-OES and 64 elemental scans for ICP-MS, single or multiple element determinations

Fraction Collection for Isolation of Impurities and Residuals

Instrumentation

Mass Spectrometers

  • Thermo LC/LTQ Orbitrap XL
  • Waters XEVO-TOF
  • Bruker MALDI-TOF/TOF
  • Agilent LC-TOF
  • Applied Biosystems Voyager DE PRO MALDI-TOF
  • Thermo LC/TSQ Vantage LC/MS/MS
  • Agilent LC-Trap
  • Agilent GC/MS

Chromatography Equipment

  • Agilent/Waters HPLC
  • Waters Acquity UPLC
  • Agilent GC
  • Headspace Autosampler

Detectors

  • Corona Charged Aerosol (CAD+)
  • Electrochemical (ECD)
  • Evaporative Light Scattering (ELSD)
  • Fluorescence (FL)
  • Laser-Induced Fluorescence (LIF)
  • Photodiode Array (PDA)
  • Refractive Index (RI)
  • Ultraviolet (UV)
  • Flame Ionization Detector (FID)
  • Thermal Conductivity Detector (TCD)