High Resolution Mass Spectrometry
2SD Toxicology Services is currently constructing a state-of-the-art High-Resolution Mass Spectrometry Facility (HRMS). This facility will feature cutting-edge bioanalytical capabilities, including:
• Extractable leachable study of medical device per ISO 10993-18 in an ISO 17025 accredited facility
• USP 661 testing (Plastic Materials of Construction and Plastic Packaging Systems for Pharmaceutical use
• Bioanalytical method development and validation for small molecule drug/xenobiotic in biological matrix per FDA/ICH M10 guidance
• Metabolite identification and profiling in blood and urine
• Non-GLP DMPK study
• On-site HRMS bioanalytical method transfer and HRMS training packages