Karl Fischer (KF) Moisture Testing Services - For the Pharmaceutical Industry

Accurate Moisture Control to Ensure Drug Quality Compliance and Stability

The moisture content level serves as a key factor that determines pharmaceutical quality as well as safety and stability throughout research and manufacturing processes. While surplus moisture produces hydrolytic degradation and microbial contamination, inadequate moisture disrupts tablet disintegration and dissolution processes. The USP, EP, and ChP pharmacopeias include particular moisture control requirements for various pharmaceutical drugs.

As a professional third-party analytical testing laboratory, we offer Karl Fischer (KF) moisture testing services in full compliance with pharmacopeial standards. We provide moisture determination services for raw materials as well as excipients, intermediates and finished dosage forms to enable pharmaceutical companies to maintain superior quality control and prepare regulatory submissions.

Karl Fischer Titration: The Gold Standard for Moisture Determination in Pharmaceuticals

Pharmaceutical industries prefer Karl Fischer titration as a pharmacopeial method because it demonstrates superior specificity and sensitivity across a wide range of applications for moisture testing.

We offer two mainstream KF testing methods:

• Volumetric KF: Suitable for samples with moisture content above 0.1%
• Coulometric KF: Ideal for accurate determination of trace moisture (in the µg range), especially in low-moisture samples such as lyophilized powders and organic solvents

Our tests are conducted based on, but not limited to, the following guidelines:

• USP <921> Water Determination
• EP 2.5.12 Water: Karl Fischer
• ChP 0832 Moisture Determination
• ICH Q2 Guidelines for Method Validation

Types of Pharmaceutical Samples We Can Test

Testing Capabilities and Quality Assurance

Equipped with advanced automatic KF titrators (supporting both volumetric and coulometric methods), we provide the following technical capabilities:

• Detection range: 1 µg to several tens of milligrams
• Limit of detection (LOD): ~1 µg (coulometric method)
• Repeatability: RSD ≤ 1.0% under typical conditions
• Flexible sample introduction: Solid sample introduction, headspace sampling, and temperature-controlled injection
• Instrument calibration traceable to NIST standard water materials

Our robust quality assurance measures include:

• Full-process blank control and system calibration before, during, and after analysis
• Standard recovery assessment and method accuracy validation
• Dual-review system and full raw data documentation to meet GMP/GLP audit requirements
• Test reports available in both English and Chinese upon request