Moravek’s cGMP quality control and analytical laboratory offers a wide range of services such as method feasibility check, method development, method transfer, API release, and stability studies that utilize our temperature controlled and continuously monitored storage chambers.
An extensive array of 21 CFR Part 11 compliant analytical equipment is operated by our highly skilled staff in a dedicated cGMP QC laboratory.
Agilent 1290 UPLCs
Agilent 7900 ICP-MS
Bruker D2 Phaser XRPD
Some of the qualified systems and instrumentation that support our quality control and analytical services include:
- 21 CFR Part 11 compliant Agilent OpenLab Enterprise Content Management System (ECM)
- Temperature, pressure and humidity monitoring of stability chambers utilizing Rees Scientific Environmental Monitoring System (EMS)
- Eight Agilent 1290 UHPLCs with ISET emulation capability
- Five Agilent 1200 HPLCs
- Bruker UltraShield 400 Plus NMR with broadband probe
- LTQ-XL and TSQ Quantum Access triple quadrupole mass spectrometers
- Agilent 5975C GC-MS
- Agilent 7900 ICP-MS
- Agilent 7890 Headspace GC
- Bruker D2 Phaser XRPD
- Malvern 2000 Mastersizer particle sizer
- Mettler XPR2U ultra-microbalance and two Mettler XP205 semi-microbalances
- Two scintillation counters
- Agilent Cary 630 FTIR spectrometer
- Mettler Toledo C10 volumetric Karl Fischer water content analyzer