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