Quality Control

Release testing of incoming raw materials, process chemicals, or intermediates to ensure compliance with material specifications.

Consistent quality in process materials is essential to the success of any manufacturing operation. By verifying incoming raw materials, process chemicals, and intermediates meet required specifications, manufacturers can assure their final products consistently meet customer expectations. CA Analytical is equipped with the technologies, proven methods, and established processes necessary to provide comprehensive quality control testing, covering the full range of material testing needs, including:

Full Monograph Compendial Testing

  • United States Pharmacopeia (USP)
  • European Pharmacopeia (Ph. EUR)
  • British Pharmacopoeia (BP)
  • JP Pharmacopoeia (JP)
  • Water Determination USP <921>
  • Light Diffraction Measurement of Particle size USP <429>
  • Visible Particulate Matter in Injections USP <790>
  • Technical Transfer of Methods into and out of CA Analytical Testing Services
  • Long Term and Accelerated Stability Storage complying with ICH requirements
  • Total Organic Carbon (TOC) & Conductivity Testing USP <643> <645>
  • Photostability Testing (ICH Q1B)
  • Osmolarity and Osmolality USP <785>
  • Residual solvents USP <467>*
  • Optical rotation USP <781>*
  • Particulate Matter in Injections USP <788>*

Testing Capabilities Include:

  • FTIR
  • HPLC and UPLC (DAD & CAD)
  • Karl Fischer (VKF & CKF)
  • Dissolution
    • USP Apparatus 1 (Baskets) and Apparatus 2 (Paddles)
    • USP  Apparatus 4 Flow through cell
  • UV/VIS
  • Wet Chemistry
  • QQQ-LC-MS
  • ICP-MS
  • Full Compendial Water testing*
  • QQQ-GC-MS*
  • GC-Headspace*
  • QTOF-LC-MS*
  • High Accuracy Liquid Particle Counting (HIAC)*

*Coming soon (Support anticipated in Q4, 2025)

Ready to test with CA?

BOOK AN APPOINTMENT
GET A QUOTE