Moravek’s cGMP quality control and analytical laboratory services include method feasibility, method development, method transfer, radiochemical stability studies, and storage.
Validated quality critical analytical equipment is operated by our trained, highly skilled staff in a dedicated QC laboratory
QC & Analytical Support
Analytical & QC qualified systems and support includes:
• 21 CFR Part 11 compliant Agilent OpenLab Enterprise Content Management System (ECM)
• Rees Scientific temperature, pressure and humidity monitoring Environmental Monitoring System (EMS)
• Six Agilent 1290 UPLCs with ISET emulation capability
• Five Agilent 1200 HPLCs
• Agilent 7900 ICP-MS
• Agilent 7890 Headspace GC
• Bruker UltraShield 400 Plus NMR with broadband probe
• Bruker D2 Phaser XRPD
• Agilent Cary 630 FTIR spectrometer
• Mettler XPR2U ultra-microbalance and two Mettler XP205 semi-microbalances
• LTQ-XL and TSQ Quantum Access triple quadrupole mass spectrometers
• Two qualified scintillation counters
• Mettler Toledo C10 volumetric Karl Fisher water content analyzer
Storage and radiolabeling stability studies utilize 21 CRF Part 11 compliant Rees Scientific temperature mapped and continuously monitored qualified stability chambers. The entire facility including the cGMP QC laboratory and stability chambers operate with backup power from a 500kW generator.
Available cGMP API storage and stability conditions include +25 °C/60% RH, +4 °C, -20 °C, and -80 °C.