Quality Control

• United States Pharmacopeia
• European Pharmacopeia
• British Pharmacopoeia
• JP Pharmacopoeia
• Water Determination <921>
• Light Diffraction Measurement of Particle size <429>
• Visible Particulate Matter in Injections <790>
• Technical Transfer of Methods into and out of CA Analytical Testing Services
• Long Term and Accelerated Stability Storage complying with ICH requirements
• Photostability Testing
• Osmolarity and Osmolality <785>
• Residual solvents <467>*
• Optical rotation <781>*
• Particulate Matter in Injections <788>*

Testing Capabilities include:

• Limulus amebocyte lysate (LAL) testing
  • Kinetic Turbidimetric, RCR, Kinetic Chromogenic
• FTIR
• HPLC and UPLC (DAD & CAD)
• Karl Fischer
• DSC
• Dissolution -USP 4 Flow cell (SOTAX)
• UV/VIS
• Wet Chemistry
• QQQ-LC-MS
• ICP-MS
• Full Compendial Water testing*
• Bioburden*
• QQQ-GC-MS*
• GC-Headspace*
• QTOF-LC-MS*
• Hi Accuracy Liquid Particle Counting (HIAC)*
• Sterility*

*Coming soon (Support anticipated in Q4, 2025)