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Water testing for manufacturing facility – Total Organic Carbon (TOC)

Purified Water TOC Testing
Manufacturing Facility Systems – USP <643> Compliance​

Overview Service

Capzer Pharmaceuticals conducts Total Organic Carbon (TOC) analysis for purified water, water for injection (WFI), and clean steam systems used in pharmaceutical manufacturing facilities. Our FDA/DEA-registered laboratory verifies organic impurity levels supporting system qualification, routine monitoring, and validation per USP <643> requirements.​

Our Approach

Samples undergo high-temperature combustion or wet-chemical oxidation followed by nondispersive infrared (NDIR) detection of generated CO₂, calibrated against potassium hydrogen phthalate standards (500 ppbC). USP <643> specifies ≤500 ppb for PW and ≤30 ppbC for WFI, with system suitability checks ensuring <15% drift between pre- and post-sample System Suitability Standards.​​

Key Capabilities

  • Online/offline TOC measurement using qualified analyzers (LOD ~1–10 ppbC).
  • Multi-point calibration and conductivity correlation per .
  • Trend reporting for PW loops, RO/DI systems, and distillation stills.​

Benefits for Partners

Partners achieve cGMP-compliant water system documentation for Gabapentin tablet and Empagliflozin API manufacturing from our ISO 17025-accredited facility, preventing batch release holds due to organic excursions.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.

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