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Device Name / Brand / Model
• Name: Karl Fischer Titration System (Coulometric) – Water Content Determination
• Brand: Mettler Toledo
• Model: C30S
Overview
Karl Fischer titration is a widely used analytical method that enables highly specific and sensitive determination of water content in samples. The coulometric approach is ideal for measuring very low moisture levels (down to the ppm range). Coulometric Karl Fischer titration directly supports formulation and manufacturing by accurately determining water content—a critical parameter for the efficacy, stability, and safety of pharmaceuticals used in targeted therapies.
Purpose / Output
• High-sensitivity water content determination in samples (ppm/µg levels)
• Residual moisture measurement in lyophilized (freeze-dried) products
• Support for quality control and process validation in moisture-sensitive products
• Reporting water content data for stability assessments
Application Areas
• Precise moisture control in biologics, protein-based therapies, and antibody formulations
• Water content determination in polymer-based drug delivery systems (microspheres, hydrogels, nanoparticles)
• Residual moisture evaluation and shelf-life support for lyophilized products
• QC and process validation for moisture-sensitive targeted drugs
Highlights
• High sensitivity for trace moisture via coulometric Karl Fischer method
• 1 µg H₂O detection limit for very low water levels
• Reliable results supported by high repeatability and accuracy
Technical Specifications
| Feature | Value / Description |
|---|---|
| Titration type | Coulometric Karl Fischer (water content determination) |
| Detection limit | 1 µg H₂O |
| Measurement range | 1 µg – 200 mg H₂O |
| Accuracy | ± (3 µg + 0.3% of reading) |
| Repeatability | < ±3 µg |
| Usage note | In operation |
Contact / Service Request
For service requests: you may email [email protected]. (Please specify the sample type, purpose, and preferred date range.)